Join

Values

Building a foundation of hope.

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases.

We are forging a team that embodies Hope:

H

Hardworking

Time is critical for patients

O

Open

Be transparent, be collaborative, be present

P

Purpose-Driven

Your actions will impact lives

E

Engaged

Seek opportunities to do better, to grow

Open Positions

Have a question? Email us at careers@forgebiologics.com

Our foundation is hope

Job Title: Technician, Process Development

We are currently seeking a Process Development Technician to join the Forge Biologics team. This is an exciting opportunity to lead the laboratory efforts and execute production processes for (upstream/downstream) Process Development. The candidate will optimize existing and implement new technologies and systems into research and GMP operations. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The PD Tech is responsible for performing the development process(es) for our most advanced AAV-based (viral vector) therapeutic candidates. The PD Tech will execute the procedures designed to demonstrate and improve developmental processes as well as the experimental processes under evaluation.

This role reports to Director of PD. The PD Tech will be responsible for upstream (cell culture & virus production) and downstream (harvest & purification) activities with the goal of eventually developing a singular “platform” process for the entire AAV program portfolio. The PD Technician will also oversee in-process analytical method development and testing. Lastly, the PD Technician will oversee the formulation and drug production filling and finishing operations.

Responsibilities:
  • Conducts Process Development laboratory activities from upstream production optimization to fill finish processes that incorporates application of GMP principles and methodologies
  • Drafting and revising process documents, manufacturing batch records, and sampling plans
  • Training junior staff in laboratory skills and scheduling lab/equipment maintenance
  • Plan and lay out work to meet production and schedule requirements from clients
  • Prepares and presents data associated with manufacturing processes and transfers activities to external clients. May serve as the Person-in-Plant support during manufacturing campaigns
  • Support internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes
  • Delivering results in a high paced environment
  • Package and ship finished product or coordinate the effort
  • Additional responsibilities not listed may be assigned as needed by leadership
Requirements:
  • Master’s or Bachelor’s Degree in biological sciences or engineering (or equivalent work experience)
  • Minimum of 2+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
  • Strong knowledge in the following system(s): Cell Culture, Pharmaceutical Utilities, Purification (FPLC), Filling, Bioreactors, Automation, Process Sterilization, and Liquid Filling/Packaging
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or product transfer activities
  • Ability to work in confined spaces and near operating equipment
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed
  • Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments
Apply

Job Title: Scientist, Process Development

We are currently seeking a Process Development Scientist to join the Forge Biologics team. This is an exciting opportunity to provide supervision and oversight of (upstream/downstream) Process Development. The candidate will lead implementation of new technologies and systems into research and GMP operations. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental/interorganizational relationships to support our growth in the Gene Therapy sector.

The PD Scientist is responsible for developing the clinical/commercial process(es) for our most advanced AAV-based (viral vector) therapeutic candidates. Once developed, the PD Scientist will oversee efforts to characterize and optimize that process as well as the development of subsequent manufacturing processes.

The Director of Research Manufacturing will be responsible for upstream (cell culture & virus production) and downstream (harvest & purification) activities with the goal of delivering a specified amount of AAV at the client’s request. The Director will also analyze in-process and release analytical testing. Lastly, the Director will oversee the formulation and drug production filling, finishing operations, and distribution of product to client.

The PD Scientist will be responsible for upstream (cell culture & virus production) and downstream (harvest & purification) activities with the goal of eventually developing a singular “platform” process for the entire AAV program portfolio. The PD Scientist will also oversee in-process analytical method development and testing. Lastly, the PD Scientist will oversee the formulation and drug production filling and finishing operations.

Responsibilities:
  • Leads Process Development laboratory activities from upstream production optimization to fill finish processes that incorporates application of GMP principles and methodologies
  • Drafting and revising process documents, manufacturing batch records, and sampling plans
  • Prepares and presents data associated with manufacturing processes and transfers activities to internal and external clients. May serve as the Person-in-Plant support during manufacturing campaigns
  • Support internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes
  • Delivering results in a high paced environment
  • Conducts the engineering effort to assure process equipment and supporting materials are in place and meet GMP requirements from design through procurement, installation and operational readiness, and associated required documentation
  • Additional responsibilities not listed may be assigned as needed by leadership
Requirements:
  • Ph.D. or master’s degree in biological sciences or engineering (or equivalent work experience)
  • Minimum of 5+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
  • Strong knowledge in the following system(s): Cell Culture, Pharmaceutical Utilities, Purification (FPLC), Filling, Bioreactors, Automation, Process Sterilization, and Liquid Filling/Packaging
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or product transfer activities
  • Ability to work in confined spaces and near operating equipment
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed
  • Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments
Apply

Job Title: Vice President of Medical Affairs

We are currently seeking a Vice President of Medical Affairs (VP) to join the Forge Biologics team. This is an exciting opportunity to design, build and lead the therapeutics division at Forge. The VP will report to the CEO and will be responsible for transitioning pre-clinical products into our clinical pipeline and managing the Clinical Operations team. The successful candidate will work closely with the CEO and CMO on clinical development strategy and will provide direction to senior leadership cross-functionally regarding all aspects of medical affairs. Key attributes for the role include strong knowledge in the orphan/rare disease and gene therapy space; direct experience with translation of products from bench side to bedside; and experience in interaction with regulatory agencies both in the United States and abroad.

Responsibilities:
  • Create and maintain relationships with Key Opinion Leaders and related groups to educate and enhance understanding of our medical programs and research towards advances in technology and treatment across multiple disease areas.
  • Develop strategic plans outlining the lifecycle of our products from preclinical research through commercialization
  • Assist in preparation of regulatory documents including INDs, briefing packages, designation requests, and BLAs
  • Assist in clinical protocol development, investigator brochure review, trial report preparation and data interpretation
  • Support and oversight of data safety monitoring and advisory board meetings
  • Participate in the hiring, training and leadership of the Clinical Operations team
  • Manage budgets, resources, performance assessments, and other key business management tasks
  • Develop and maintain business relationships at all levels to ensure the continued growth of business
  • Ensure team activities are consistent with Forge values and aligned with our mission to accelerate transformative medicines to those who need them most
  • Enable consistent dialogue and support stakeholder management to establish partnerships with alliance organizations and commercial counterparts
  • 20%-40% travel anticipated
Requirements:
  • Advanced degree (MD) with sciences major required
  • 5-7 years clinical experience in biotech, pharmaceutical or relevant clinical CRO experience.
  • Experience in execution of rare disease or gene therapy clinical trials required, including experience in both Phase 1 studies and larger, multi-center trial management
  • Demonstrated experience interacting with FDA and EMA
  • Well versed in GCP and applicable FDA/EMA regulations required
  • Ability to prepare and present clinical trial updates to Board members and investors
Apply

Job Title: Director, Quality Control
Reports to: Senior Director, Quality Management

We are currently seeking a Director of Quality Control to join the Forge Biologics team. In this role, the Director of Quality Control (QC) actively contributes to the strategic, operational, and laboratory activities required to support the method transfer, validation, sample testing, and review/approval of related reports. The Director manages the assets and personnel in the QC department and the QC activities for both internal and external gene therapy programs. This includes, but may not be limited to, stability testing and Drug Substance (DS)/Drug Product (DP) release.

This is an exciting opportunity to provide leadership and oversight of the required support services and systems to make our organization successful. The candidate will lead a team of scientists, analysts, and technicians to work with vendors, internal users, and external clients to support GMP and business operations. The candidate will serve to assure all groups are properly supported and integrated into new systems and communications to support future growth and the Forge strategic vision.

Working in a matrix management environment that includes Analytical Development, Clinical and Commercial Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, the candidate will be responsible for maintaining a detailed understanding of the status of each program in order to prioritize and effectively execute on QC-related activities.

The Director of QC will have oversite of the Analytical, Micro, Physical Monitoring, and Environmental Monitoring teams at Forge. These teams serve a wide array of internal and external customers and require close coordination with Quality and Regulatory groups as well. Additionally, the Director will set-up and maintain and trend these systems. The Director will play a crucial role in developing and maintaining these teams and will be the local subject matter expert for all regulatory inspections for these applications. Additionally, the candidate will lead/participate in addressing Regulatory Agency responses resulting from CTA/IND and BLA/MAA applications.

The Director will take part in coordinating and participating in construction efforts for continued growth of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all Operations leadership, and/or external parties to support GMP manufacturing of clinical drugs. The focus of this management role is to employ learned approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the Director of QC will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Role Description:
  • Provides strategic and operational management of a Quality Control department responsible for performing assays relevant to viral vector/gene therapy products, including in-process testing, in-process control, lot release, and formal stability testing.
  • Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
  • Works with the Analytical Development (AD) organization (Assay Development, non-GMP testing group, etc.), and across the GMP Operations team more broadly, to ensure effective communication between all groups.
  • Assist in clinical protocol development, investigator brochure review, trial report preparation and data interpretation
  • Provides management for and ensures the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
  • Participate in the hiring, training and leadership of the Clinical Operations team
  • Ensures a science-driven, phase appropriate, and risk-based Quality Control strategy to support development projects from product selection to clinical development and commercial manufacture for internal therapeutic programs.
  • Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings.
  • Ensures adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
  • Manages and mentors staff to build a highly functional QC team that may be cross-trained in analytical development assay areas, as needed.
  • Builds the scientific knowledge, capabilities, and strategies in gene therapy QC that enable fast to clinic/fast to market product development and commercialization.
  • Works directly with Senior Leadership to assure process communications are occurring in a timely manner and budget and timelines are being adhered to.
  • Subject matter expert (SME) that participates in the engineering effort to assure analytical equipment and supporting materials are in place and meet current GMP requirements from design through procurement, installation and operational readiness, and associated required documentation.
  • Supports business development activities including vendor and contractor selection as well as resource and response generation for bids and project budgeting.
  • Supports future business evolution through process knowledge expansion and supporting internal product and process development activities.
Requirements:

PhD in molecular biology, virology, biochemistry, or related discipline and a minimum of 9 years of experience in biologics and/or gene therapy QC roles, OR Master’s degree in these same disciplines and a minimum of 10 years of relevant experience, OR Bachelor’s degree in these same disciplines and a minimum of 15 years of relevant experience.

Special Knowledge or Skills Required:
  • Comprehensive experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
  • Expert knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
  • Expert level knowledge of CMC analytical and regulatory requirements.
  • Expert level knowledge of cGMP requirements as they pertain to Analytical Development and Quality Control testing.
  • Expert level laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
  • Functional knowledge of mammalian cell culture.
  • Prior experience with commercial release testing within CROs/CMOs.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Excellent oral and written communication skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Ability to present to and interact with Senior Leadership.
Special Knowledge or Skills Preferred.
  • Minimum of 6+ years’ experience in leadership/management/supervision with a preference toward direct Gene Therapy/Cell Therapy industry experience.
  • Small company and/or start-up experience.
  • Experience in high-level interactions with domestic and international Regulatory agencies.
  • Travel requirements: 0 to 15%
Apply

Job Title: Technician, Quality Control
Reports to: TBD

We are currently seeking a Quality Control (QC) Technician to join the Forge Biologics team. This is an exciting opportunity to lead the laboratory efforts and execute characterization testing and assays for Quality Control. The candidate will optimize existing and implement new technologies and systems into Quality Control for research and GMP purposes. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The QC Technician may be responsible for performing the in-process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories, as well as raw materials, to ensure they conform to manufacturer specifications. The QC Technician will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation.

The QC Technician may be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular “platform” process for the entire AAV program portfolio.

Responsibilities:
  • Conducts Environmental Monitoring/Microbiological, Chemistry, and/or Biochemistry testing (e.g., microbial testing, titering by PCR, etc.) that incorporates application of GMP principles and methodologies.
  • Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
  • Drafts and revises process documents, assay methods, and sampling plans.
  • Trains junior staff in laboratory skills and scheduling lab/equipment maintenance.
  • Plans work to meet production and schedule requirements from clients (internal and external).
  • Prepares and presents data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
  • Reviews and trends QC data (environmental monitoring, microbiological, chemistry, and/or biochemistry) and publishes trend reports on a routine basis.
  • Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.
  • Delivers results in a high paced environment.
  • Supports packaging and shipping finished product and/or coordinates the effort.
  • Additional responsibilities not listed may be assigned as needed by management.
Requirements:
  • Minimum Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
  • Minimum 2 years’ experience in a Quality Control laboratory; GMP QC laboratory strongly preferred.
  • Must be self-motivating, organized, and proactive.
  • Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Ability to work in confined spaces and near operating equipment.
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
  • Travel on an infrequent basis is required (5%) to support job responsibilities and commitments.
Special Knowledge or Skills Preferred.
  • Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
  • Experience with an electronic Document Management System.
  • Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
  • Knowledge of biopharmaceutical manufacturing process workflows.
  • Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.
Apply

Job Title: Technician, Research Manufacturing
Reports to: Manager, Research Manufacturing

We are currently seeking a Research Manufacturing Technician to join the Forge Biologics team. This is an exciting opportunity to join and execute production processes (upstream and/or downstream) for pre-clinical viral vector manufacturing. The candidate will perform biomanufacturing procedures to prepare pre-clinical vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

This position reports to the Manager of Research Manufacturing and is responsible for the production of recombinant adeno-associated virus (rAAV) vectors via maintenance of mammalian and insect cell lines, transfection, infection, and downstream purification of rAAV by chromatography and ultracentrifugation. You will utilize shake flasks and bioreactors for scale up experiments. You will also be directly involved in scalable downstream purification technologies for rAAV using FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data and contributing to protocols and study reports with supervision. It is expected that you will work as a member of the production team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:
  • Maintain cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
  • Execute downstream purification technologies related to rAAV purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
  • Compile experimental data with minimal oversight and contribute results for publications or reports
  • Support internal process transfer activities from Process Development
  • Delivering results in a high paced environment
  • Maintains records and files of work and revisions.
  • Package and ship finished product to clients in accordance with procedures and regulations
  • Additional responsibilities not listed may be assigned as needed by leadership
Requirements:
  • Bachelor’s Degree in biological sciences or engineering (or equivalent work experience)
  • Technical proficiency required for aspects of cell line growth and production of biological product
  • Working knowledge of upstream production techniques; experience with bioreactors is preferred
  • Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, Pilot) FPLC is preferred
  • Experience with production of biologics and performing bioassays is preferred
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or product transfer activities
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed
Reporting Outline:
  • This position reports to the Manager of Research Manufacturing
  • Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments
Apply

Job Title: Scientist, Research Manufacturing
Reports to: Manager, Research Manufacturing

We are currently seeking a Research Manufacturing Scientist to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the laboratory efforts and production processes (upstream and/or downstream) for pre-clinical viral vector manufacturing. The candidate will perform biomanufacturing procedures to prepare pre-clinical vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

This position reports to the Manager of Research Manufacturing and is responsible for the production of recombinant adeno-associated virus (rAAV) vectors via maintenance of mammalian and insect cell lines, transfection, infection, and downstream purification of rAAV by chromatography and ultracentrifugation. You will utilize shake flasks and bioreactors for scale up experiments. You will also be directly involved in scalable downstream purification technologies for rAAV using FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data and contributing to protocols and study reports with supervision. It is expected that you will work as a member of the production team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:
  • Maintain cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
  • Execute downstream purification technologies related to rAAV purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
  • Compile experimental data with minimal oversight and contribute results for publications or reports
  • Support internal process transfer activities from Process Development
  • Delivering results in a high paced environment
  • Package and ship finished product to clients in accordance with procedures and regulations
  • Train and mentor junior laboratory technicians
  • Additional responsibilities not listed may be assigned as needed by leadership
Requirements:
  • Master’s Degree with 8+ years’ experience in biopharmaceutical manufacturing/Research and Development; Ph.D. in biological sciences is preferred (or equivalent work experience)
  • Technical proficiency required for aspects of cell line growth and production of biological product
  • Working knowledge of upstream production techniques; experience with bioreactors is preferred
  • Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, Pilot) FPLC is preferred
  • Experience with production of biologics and performing bioassays is preferred
  • Experience working in a cGMP environment is preferred
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or product transfer activities
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed
Reporting Outline:
  • This position reports to the Manager of Research Manufacturing
  • Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments.
Apply

Job Title: Maintenance Specialist
Reports to: Director, Supply Chain & Facilities
Role Description:

We are currently seeking a Maintenance Specialist to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by supporting general maintenance efforts as it relates to HVAC and electrical infrastructure. This role will assist with installing, maintaining, and repairing electrical wiring, equipment, and fixtures and ensure that work is in accordance with relevant codes. Candidate will install or service lighting, electrical generation or other electrical control systems at our Columbus, Ohio facility, as well as review and assist as a Subject Matter Expert (SME) on vendor selection and contract completion.

Responsibilities:
  • Directs, trains, and/or individually installs, maintains, or repairs electrical wiring, equipment, or fixtures related to facility operation
  • General Plant Maintenance (Mechanical, Structural, Electrical)
  • Performs business management duties, such as maintaining records or files, preparing reports, or ordering supplies or equipment
  • Plans, lays out, and installs electrical wiring, equipment, or fixtures, based on job specifications and local codes
  • Tests and inspects electrical systems or continuity of circuits in electrical wiring, equipment, or fixtures, using testing devices, such as ohmmeters, voltmeters, or oscilloscopes, to ensure compatibility and safety of system
  • Uses a variety of tools or equipment, such as power construction equipment, measuring devices, power tools, and testing equipment, such as oscilloscopes, ammeters, or test lamps
  • Prepares sketches or follows blueprints to determine the location of wiring or equipment and to ensure conformance to building and safety codes
  • Diagnoses malfunctioning systems, apparatus, or components, using test equipment and hand tools to locate the cause of a breakdown and correct the problem
  • Advises management on whether continued operation of equipment could be hazardous
  • Constructs or fabricates parts, using hand tools, according to specifications
  • Supports all operational conditions across the site to assure seamless operation of the facility on a 24/7/365 basis as required
  • Gowns as required to enter confined spaces and controlled cGMP environments to assure facility operations
Requirements:
  • High School diploma or equivalent
  • Certifications in relevant field such as Electrical or HVAC
  • Minimum of 8 years’ experience in maintenance and support roles
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology.
Reporting Outline:
  • This position reports to the Director of Supply Chain & Facilities
  • Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.
Apply

Job Title: Director, cGMP Manufacturing Operations
Reports to: Chief Operating Officer (COO)

We are currently seeking a Director of cGMP Manufacturing Operations to join the Forge Biologics team. In this role, the Director of Manufacturing actively contributes to the strategic, operational, and production activities required to support the cGMP manufacturing programs and vision. The Director manages the cGMP assets and personnel in the operations department for both internal and external gene therapy programs.

This is an exciting opportunity to provide leadership and oversight of the required services and systems to make our organization successful. The candidate will lead a team of managers, scientists, analysts, and technicians to work with vendors, internal users, and external clients to support GMP and business operations. The candidate will serve to assure all groups are properly supported and integrated into new systems and communications to support future growth and the Forge strategic vision.

The Director will have oversite of the upstream and downstream manufacturing teams and will be responsible for coordination of these teams in synergy with all internal groups to assure schedule attainment for our internal and external clients. The Director will play a crucial role in developing and maintaining these teams and will be the local subject matter expert for all regulatory inspections for all manufacturing related activities. Additionally, the candidate will lead/participate in addressing Regulatory Agency responses resulting from CTA/IND and BLA/MAA applications.

The Director will take part in coordinating and participating in construction efforts for continued growth of the facility as well as the continued support of the facility moving forward. The individual chosen for this position will work in close partnership with all branches of the Forge leadership team, and/or external parties to support GMP manufacturing. The focus of this management role is to employ learned approaches to ensure Forge provides and maintains a state of the art AAV facility for pre-clinical, clinical, and commercial viral vector products, working in close partnership with internal and external experts to realize this goal.

The Director will also have a prominent role in working with new clients and the business development team at Forge Biologics. Strategic vision and collaborative partnerships are required for Forge to be successful as we execute our phased build plan.

To this end, the Director of cGMP Manufacturing Operations will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Role Description:
  • Provides strategic and operational management of manufacturing department responsible for producing viral vector/gene therapy products.
  • Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
  • Works with the all internal teams at Forge and across the GMP Operations team to ensure effective communication between all groups.
  • Assists and coordinates review of all manufacturing protocols, reports, records, procedures, and batch documentation to assure compliance and completeness.
  • Provides management for and ensures the effective transfer of manufacturing methods to and from external groups in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
  • Participates in the hiring, training and leadership of the Manufacturing Operations team
  • Ensures a science-driven, phase appropriate, and risk-based manufacturing strategy to support development projects from clinical to commercial manufacture for internal therapeutic programs.
  • Ensures adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
  • Manages and mentors staff to build a highly functional operations team that may be cross-trained in multiple areas, as needed.
  • Builds the scientific knowledge, capabilities, and strategies in gene therapy manufacturing group that enables high paced product development and commercialization.
  • Works directly with Senior Leadership to assure process communications are occurring in a timely manner and budget and timelines are being adhered to.
  • Operates as the Subject matter expert (SME) that participates in the engineering effort to assure manufacturing equipment and supporting materials are in place that meet current GMP requirements from design through procurement, installation and operational readiness, and contains associated required documentation.
  • Supports business development activities including vendor and contractor selection as well as resource and response generation for bids and project budgeting.
  • Supports future business evolution through process knowledge expansion and supporting internal product and process development activities.
Requirements:

PhD in biology, virology, chemistry, or related discipline and a minimum of 10 years of experience in biologics and/or gene therapy manufacturing roles, OR Master’s degree in these same disciplines or business and a minimum of 12 years of relevant experience, OR Bachelor’s degree in these same disciplines or business and a minimum of 15 years of relevant experience.

Special Knowledge or Skills Required:
  • Comprehensive experience with the GMP manufacturing techniques and regulatory requirements for cell and gene therapy products.
  • Expert level knowledge of CMC analytical and validation requirements.
  • Expert level knowledge of mammalian cell culture.
  • Expert level knowledge of aseptic processing and technique.
  • Prior experience with commercial manufacturing within CROs/CMOs.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Excellent oral and written communication skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Ability to present to and interact with Senior Leadership.
Special Knowledge or Skills Preferred.
  • Minimum of 10+ years’ experience in leadership/management/supervision with a preference toward direct Gene Therapy/Cell Therapy industry experience.
  • Small company and/or start-up experience.
  • Experience in high-level interactions with domestic and international Regulatory agencies.
  • Travel requirements: 0 to 15%
Apply

Job Title: Clinical Trial Manager
Position Description

We are currently seeking a Clinical Trial Manager (CTM) to join the Forge Biologics team. The CTM will be an integral part of the Clinical Development team by managing clinical trials through launch, execution and close out. The CTM will report directly to the Director, Clinical Program Management and will also work with the Regulatory Affairs, Patient Advocacy/Community Engagement and Product Development teams to ensure that clinical trials are conducted in a timely fashion and in compliance with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. Key attributes for the role include experience with gene therapy and rare diseases, ability to work independently, and to efficiently perform multiple tasks and manage changing priorities.

Key Responsibilities:
  • Support development of study-related documents including site feasibility, informed consent documents, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials.
  • Works with study team to design clinical trial protocol and assists in developing/managing ongoing data review to ensure detection of data trends and to ensure study objectives are met
  • Tracks the progress of the clinical trial including patient recruitment, trial supplies and trial documentation through dedicated study tools
  • Oversee the Trial Master File (TMF) and conduct periodic reviews for completeness
  • Participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics
  • Provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
  • Leads study-specific meetings including regular internal updates, site operations, safety review and CRO oversight
  • Leads DSMB meetings, including preparation of pre-meeting reports and post-meeting minutes in collaboration with the CRO
  • Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations; participates in site monitoring visits as appropriate
  • Support patient enrollment efforts and help ensure data collection are completed in accordance with study timelines and objectives
  • Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals.
  • Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations
  • Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of clinical trial material
  • Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs; ensure audit-ready conditions of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
  • Identify issues, recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues
  • Manage external relationships critical to the success of clinical programs including investigational sites, key opinion leaders and other external partners
  • Actively participate in department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Development.
  • Travel on an infrequent basis is required (<10%) to support job responsibilities and commitments
The successful candidate has:
  • Bachelor’s degree
  • 5+ years of direct experience in clinical trial execution
  • Knowledge of GCPs, ICH guidelines and FDA regulations.
  • Experience with rare disease clinical trial management
  • Experience with gene therapy clinical trials
  • Excellent communication (verbal and written), organizational and problem-solving skills
  • Experience developing and managing clinical trial budgets
  • Experience managing external contract research relationships
  • Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook
  • Excellent interpersonal skills and the ability to work well in small teams and with a wide range of varying stakeholders
  • Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments
Apply

Job Title: Manager, Research Manufacturing
Reports to: Chief Technical Officer
Role Description:

We are currently seeking a Manager of Research Manufacturing to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and oversight of upstream and downstream  vector  production.  The  candidate  will  lead  a  team  of  skilled  technicians  and scientists to produce research and toxicology grade rAAV vectors. The ideal candidate will be an expert in technical problem- solving, laboratory techniques, and developing interorganizational relationships to support our growth in the Gene Therapy sector.

This position is responsible for overseeing production of research-grade recombinant adeno- associated virus (rAAV) vectors in mammalian and insect cell lines. The incumbent will offer hands-on leadership of the production group utilizing shake flasks and single-use bioreactors for upstream work, and FPLC systems, tangential flow filtration, centrifugation, and other downstream purification technologies. Work activities will also include scheduling, equipment management, preparing protocols and study reports related to production work with minimal supervision. The Manager will review relevant literature, data of team scientists and associates, and ensure that all staff are properly trained.    It is expected that the incumbent will work independently while accomplishing the timely completion of assignments and necessary resolution of unexpected technical issues.

The individual chosen for this position will work in close partnership with manufacturing leadership, and external parties to support manufacturing of vector candidates. The Manager will also  work  closely  with  the  Directors  of  Process  and  Analytical  Development  to  facilitate seamless movement of projects through the development continuum. The focus of this leadership role is to employ novel approaches to ensure Forge provides and maintains a state-of-the-art rAAV manufacturing platform process for viral vector products, working in close partnership with internal and external experts to realize this goal.

To this end, the Manager of Research Manufacturing will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development and manufacturing plans.

Responsibilities:
  • Schedule and adhere to daily, weekly, and monthly production targets for internal and external clients
  • Organize workflow and clearly communicate duties and tasks to direct reports
  • Participate,  oversee,  and  communicate  priorities  for  the  execution  of  upstream  and downstream manufacturing procedures for simultaneous batches
  • Maintaining cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
  • Execution  of  downstream  purification  technologies  related  to  rAAV  purification  using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
  • Assist in the production of preclinical and toxicology materials in a laboratory setting
  • Perform vector characterization assays (qPCR, SDS-PAGE, Western blotting, etc.) on in- process and final samples on as needed basis
  • Preparing protocols and reports in notebooks and electronic documents
  • Train junior staff in the various upstream, downstream, and analytical techniques
  • Oversee inventory management for the group in coordination with materials management group to keep lab well stocked and organized
  • Track production and quality metrics
  • Interface with other departments (Analytical Development, Process Development, Program teams, etc.) as necessary
  • Communicate production schedule and vector data to management, program managers, and clients
  • Ensure  that  operations  adhere  to  the  plant  schedule  and  critical  activities  are  always performed within the allotted timeframes
  • Support  business  development  activities  including  vendor  and  contract  manufacturer selection as well as resource and response generation for bids and project budgeting
  • Support future business evolution through process knowledge expansion and supporting internal product and process development activities
  • Additional responsibilities not listed may be assigned as needed by leadership.
Requirements:
  • Bachelor’s degree with 8+ years’ relevant experience; or Master’s degree with 6+ years’ direct experience, or Ph.D. with the completion of a postdoctoral fellowship in biological sciences or two years’ of relevant experience in biopharmaceutical manufacturing/R&D
  • Technical proficiency required for aspects of production of biological products
  • Experience in production of viral vectors is preferred
  • Broad knowledge of cell culture techniques is required; experience with bioreactors is preferred
  • Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, or Pilot) or Bio-Rad NGC FPLC systems is highly preferred
  • Experience with production of biologics and performing bioassays is preferred
  • Previous experience in training and oversight of direct reports is required
  • Experience working in a cGMP environment is preferred
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or product transfer activities
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed
Reporting Outline:
  • This position reports to the CTO
  • Travel  on  an  intermittent  basis  is  required  (approximately  5-10%)  to  support  job responsibilities and commitments
Apply

Job Title: Senior Scientist, Process Development
Reports to: Director, Process Development
Role Description:

We are currently seeking a Senior Scientist to join the Forge Biologics team. This is an exciting opportunity to lead efforts and characterize bioprocess methods to support viral vector manufacturing. The candidate will lead downstream biomanufacturing development and support upstream development in the manufacturing of viral vector for clients at various scales ranging from 500mL to 500L. The ideal candidate will be highly skilled in technical problem-solving and bioprocessing techniques to support our growth in the Gene Therapy sector.

This position reports to the Director of Process Development and is responsible leading downstream process development activities for production of recombinant adeno-associated virus (rAAV) vectors. You will oversee and perform scalable downstream purification technologies for rAAV using depth filtration, FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data, writing protocols and study reports, and presenting findings to internal and external parties with minimal supervision. It is expected that you will lead and participate as part of the process development team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Responsibilities:
  • Independently design, execute, and analyze experiments optimizing production and purification of AAV
  • Directly supervise the downstream activities of the Process Development Lab – manage experiments, equipment, inventory, and workloads
  • Compile and review experimental data with minimal oversight and author publications, protocols, or reports
  • Support large-scale manufacturing runs and ensure timely delivery of materials to internal and external partners
  • Delivering results in a high paced environment
  • Train and mentor junior laboratory technicians
  • Additional responsibilities not listed may be assigned as needed by leadership
Requirements:
  • Master’s Degree or higher in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or related and 8+ years’ experience, or PhD degree preferred, with 2+ years’ experience
  • Practical experience with FPLC is a must, ideally at both Lab and Pilot scales
  • Experience with other aspects of downstream purification (e.g. – clarification/filtration, TFF, etc.) is required
  • Experience with suspension cell culture at all scales: flasks, bench-top bioreactors, and large-scale single-use bioreactors is preferred
  • Experience with purification of vaccines or viral vectors is preferred
  • Proficiency with MS Excel, GraphPad Prism, and electronic lab notebooks is essential
  • Proficiency designing, executing, and analyzing DOE is highly desired
  • Must be self-motivating, organized and proactive
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Must have excellent verbal and written communication skills
  • Must have demonstrated experience effectively managing multiple projects and staff
  • Ability to work hours necessary to support development and/or product transfer activities.
  • Must be able to work independently, but is also a team player with strong collaborative skills
Reporting Outline:
  • This position reports to the Director of Process Development
  • Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments.
Apply

Job Title: Research Associate, Analytical Development
Job Description:

As a member of the Analytical Development group this position will help drive the development of Forge Biologic’s in-house programs as well as client programs. You will be responsible for the development of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays supporting the gene therapy analytical development organization. This position is also responsible for clear and timely documentation of assay results and communicating data to supervisor. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs).

Primary Responsibilities Include:
  • Performing product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for gene therapy product process development and manufacturing. These include, but may not be limited to DNA/RNA isolation, qPCR, RT-qPCR, ddPCR, ELISA, SDS-PAGE and Western Blot
  • Compiling experimental data with minimal oversight, generating reports, and archiving assay data.
  • Assist the gene therapy process development team in the analysis and interpretation of assay results.
  • Support the analytical and process development group's daily operational needs by maintaining assay cell lines, controls, standards, and reagent inventories.
  • Apply relevant scientific principles and techniques to analytical development problems.
  • Maintain detailed, up to date, and reviewed laboratory notebooks.
Education and Skills Requirements:
  • A Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline and a minimum of 4 years of relevant experience in a pharmaceutical, biotechnology or related environment or a Master’s degree in these same disciplines and a minimum of 2 years of relevant experience in these same environments
  • Proficiency with the conduct of qPCR, cell-based assays, and immunoassays is preferred
  • Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is preferred
  • Proficiency with Microsoft Office
  • Excellent verbal and written communication skills
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Ability to work with a high attention to detail
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
Apply

Job Title: Scientist, Analytical Development
Job Description:

As a member of the Analytical Development group this position will help drive the development of Forge Biologic’s in-house programs as well as client projects. You will be responsible for the design and optimization of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays for evaluation of final and in- processes for gene therapy vectors. This position is also responsible for clear and timely documentation of assay results and communicating data to supervisor, as well as reviewing the data of junior team members. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) .

Primary Responsibilities Include:
  • Design and execute cell culture experiments and bioanalytical assays to support manufacturing, purification and clinical comparability of AAV gene therapy products
  • Design, optimize and perform analytical assays such as DNA/RNA isolation, qPCR, RT-qPCR, ddPCR, ELISA, SDS-PAGE and Western Blot
  • Perform AAV infectivity titration and neutralization assays
  • Work seamlessly with cross functional stakeholders including Process Development, Product Development, and Quality Control to help advance the AAV vector production portfolios
  • Participate in project related teams and other internal/external collaborations
  • Maintain clean and fully functional laboratory and adhere to all laboratory standards as defined in SOPs
  • Ensure that scientific and technical challenges are resolved in a timely manner
  • Contribute to a safe, efficient, and effective environment with personal accountability
Education and Skills Requirements:
  • PhD in Molecular Biology, Biotechnology, Biochemistry, Immunology, Virology, or a related field with 0-2+ of relevant experience, or MS with 6+ years of related experience in assay development
  • Experience with aseptic techniques in mammalian cell culture systems and performing bioassays
  • Technical proficiency in quantitative PCR
  • Experience in gene therapy and/or vaccine testing is preferred
  • Prior experience performing viral genome titer, infectivity, potency, host cell protein, and host cell DNA assays is preferred
  • Experience with ddPCR, ELISA, SDS-PAGE and Western Blot is preferred
  • Knowledge of analytical ultracentrifugation techniques is desirable
  • Excellent written and verbal communication skills
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Ability to work with a high attention to detail with minimal supervision
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
  • Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
Apply

Job Title: GMP Associate (multiple positions)
Reports to: Director GMP manufacturing Operations
Role Description:

We are currently seeking a GMP Associate to join the Forge Biologics team. This is an exciting opportunity to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will participate in GMP manufacturing campaigns and provide hands-on support for new technologies and systems in our GMP manufacturing facility. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The GMP Associate provides manufacturing and operational expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The GMP Associate responsibilities include, but are not limited to; training, sampling, manufacturing activities, method qualification/validations, investigations, and cleaning support. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Operations Management. The GMP Associate may also support the Operations management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The GMP Associate may be responsible for performing the manufacturing and in- process sampling for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories. The GMP Associate will execute the procedures designed to assure safety, efficacy, and purity of the drug products being manufactured. The GMP Associate may be responsible for upstream (cell culture and virus production) and/or downstream (harvest and purification) manufacturing activities to support a processes for the entire AAV program portfolio.

Responsibilities:
  • Performs manufacturing activities and sampling that incorporates application of GMP principles and methodologies.
  • Supports thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.
  • Trains junior staff in laboratory skills and scheduling lab/equipment.
  • Plans work to meet production and schedule requirements from clients (internal and external).
  • Prepares data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
  • Supports internal process transfer activities and may serve as Subject Matter Expert (SME) to troubleshoot processes.
  • Delivers results in a high paced environment.
  • Supports packaging and shipping finished product and/or coordinates the effort.
  • Additional responsibilities not listed may be assigned as needed by management.
Requirements:
  • Minimum Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
  • Minimum 1-2 years’ experience in a GMP or QC environment strongly preferred.
  • Must be self-motivating, organized, and proactive.
  • Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Ability to work in confined spaces and near operating equipment.
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
  • Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.
Special Knowledge or Skills Preferred:
  • Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
  • Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
  • Knowledge of biopharmaceutical manufacturing process workflows.
  • Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.
Apply

Job Title: Janitor
Reports to: Facilities Manager
Role Description:

We are currently seeking a Janitor to join the Forge Biologics team. We are a fast-growing gene therapy startup building out a 175,000 square foot facility in Grove City. This position will start off working onsite for 30 hours per week and the hours will increase as the space grows. This person must be responsible for cleaning the assigned areas within the facility and keeping everything in orderly condition. At Forge Biologics we'll help you reach your potential while you help others reach theirs. Want to enjoy coming to work? So do we!

Responsibilities:
  • Maintain cleanliness in general office and common areas: entrance glass and doors, water fountains, elevators, stairwells, and furniture.
  • Empty trash cans and change liners.
  • Clean floors using the appropriate product as well as dust mops, wet mops, and vacuum cleaners.
  • Disinfect and clean restrooms, including all equipment, fixtures and stainless steel. Refill paper towels, toilet paper and soap.
  • Spot clean carpets as needed.
  • Use floor scrub machine to clean tile floors as well as bathroom floors.
  • Operate machines such as floor buffers and carpet cleaners as needed.
  • Utilize all available cleaning tools and products to ensure a well-kept environment.
  • Train new employees as requested and report progress to supervisor.
  • Perform other related duties as assigned.
  • Manage products needed for day to day operations.
Requirements:
  • Equivalent combination of education, training and experience will be considered.
  • Minimum of three years of experience in housekeeping or custodial work.
  • Ability to operate cleaning machines and equipment.
  • Clear verbal communication skills and ability to give and follow written and oral instructions.
  • Ability to effectively organize and prioritize work as well as concentrate on multiple tasks simultaneously.
  • Ability to work independently and make responsible decisions.
  • Ability to use good judgment and think quickly and rationally in difficult or stressful situations.
Work Environment & Physical Abilities:
  • Exposed to moderate noise levels.
  • Exposed to potentially hazardous bodily fluids or chemicals, and fumes or airborne particles.
  • May be exposed to extreme heat or cold in buildings or rooms that are not climate-controlled.
  • Must be able to stand, walk, reach, bend, balance, grasp and push for extended periods of time.
  • Will perform repetitive wrist, hand and/or finger movement.
  • Will move up and down from/to sitting position on the floor.
  • Regularly lift and/or carry up to 10 pounds; heavier lifting is occasionally required.
  • Regular attendance is a necessary and essential function.
Apply

Job Title: Manager, Regulatory Affairs-CMC
Reports to: VP, Regulatory Affairs
Role Description:

Forge Biologics, Inc. seeks an experienced Regulatory Affairs Manager to join our growing team. This role will be accountable for the preparation and management of CMC (chemistry, manufacturing, and control) components for dossiers and submissions of Module 2.3 and Module 3 CTD (common technical document) sections, Drug Master Files (DMFs), Site Master Files (SMFs) and related progress reports, amendments, supplemental applications. This includes continued maintenance of these CMC regulatory submissions to the FDA, EMA and other global regulatory agencies. This role works across functional groups and directly with external client teams to propose strategies and solutions. Responsibilities include coordination and management of CMC change control and related databases for clinical and commercial applications. The position will support compliance with regulatory authority regulations and interpretations with opportunities to interact with global regulatory agency personnel.

A strong candidate will demonstrate independent project management, document creation and lead the integration of regulatory filings with various teams including operations, quality, external clients, and external CROs and consultants in the planning, organization, and preparation of regulatory documents. Excellent written and effective verbal communication skills along with flexibility and ability to work in a fast-paced environment are a must.

Responsibilities:
  • Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies
  • Ensure that the content and structure of documents meet established regulatory requirements.
  • Actively contribute to the development and implementation of regulatory strategy for assigned projects.
  • Liaise as CMC representative across functional groups, client teams, international regulatory groups and business partners, propose strategies and solutions at level of personal technical experience and identify issues that may delay project timelines.
  • Provide support for other members of the department on the basis of workload.
  • Prepare, coordinate, manage or maintain regulatory CMC documentation submissions (e.g., Module 2.3 & Module 3 CTDs, DMFs, amendments, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
  • Provide thoughtful & accurate comments during document development and review, aware of regulatory/USP/ISO/ICH guidance/requirements pertaining to document content.
  • Interface with external regulatory groups (e.g., CRO, partners, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
  • Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines).
  • Author and review standard operating procedures (SOPs); provide review that SOPs are in compliance with current regulatory requirements and support for corporate quality assurance efforts.
  • Develop and maintain current regulatory knowledge.
  • Coordinate with external API and critical material supply partners to manage regulatory submissions.
  • Participate and support client quality audits and regulatory and health authority site inspections and pre-approval inspections of manufacturing facility and supporting systems.
The Ideal Candidate:
  • Bachelor’s degree in a scientific discipline or equivalent. Advanced degree or Regulatory Affairs Certification is preferred.
  • Candidate must have at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
  • Prior experience in providing client-based external consultation is preferred.
  • Must have experience independently preparing and submitting documents in an eCTD compliant manner and assigning STFs.
  • Must have a solid understanding of FDA regulations and ICH guidance, as well as a comprehension of the drug development process.
  • Experience with regulatory submissions in Common Technical Document format is essential.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • High level of attention to detail, and be proficient with Microsoft Office applications, Adobe, Sharepoint, and document management templates. Experience with eCTD publishing software is preferred.
Reporting Outline:
  • This position reports to VP of Regulatory Affairs
  • Travel on an intermittent basis is required (approximately 10-20%) to support job responsibilities and commitments.
Apply

Job Title: Technical Writer
Reports to: Director, Supply Chain & Facilities
Role Description:

We are currently seeking a Technical Writer to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by authoring, reviewing and processing documents needed for our Columbus, Ohio operations. The candidate will collaborate with site Subject Matter Experts (SMEs) in order to transcribe process, procedure and work instructions into usable documents that will support our Quality Management System and adhere to cGMP principles. The ideal candidate will be skilled in technical writing, understand and learn new processes quickly, as well as write and translate various subject matters clearly and in a concise manner that will support our employee training efforts.

The Technical Writer is responsible for authoring documents in support of all current departments at the Columbus facility. These areas include Safety, Quality, Training, Regulatory, Maintenance, Development, Operations, and Validation efforts. The Technical Writer will also support all new documents that may be deemed necessary as business requires. This role reports to the Director of Supply Chain & Facilities. The Technical Writer will be responsible for supporting Process, Product, and Analytical Development, as well as any cGMP/Commercial processes.

Responsibilities:
  • Writes, edits, and reviews cGMP manufacturing documents, validation protocols, SOPs, and development related material in support of Development, Analytical, and Operations activities, while maintaining standardized and consistent documentation practices for recording details of new processes for the manufacture of biopharmaceutical products.
  • Organizes material according to set standards regarding order, clarity, conciseness, style, and terminology.
  • Edits, standardizes, or suggests changes to material prepared by other writers or Forge personnel to verify accuracy, consistency, grammar, and format.
  • Maintains records and files of work and revisions.
  • Collaborates with Development and Operations personnel to become familiar with product technologies and production methods.
  • Observes production, developmental, and experimental activities to determine operating procedure and detail.
  • Selects photographs, drawings, sketches, diagrams, and charts to illustrate material.
  • Studies drawings, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail.
  • Reviews manufacturer's manuals and trade catalogs, drawings and other data relative to operation, maintenance, and service of equipment.
  • Confers with customer representatives, vendors, facility executives, or publishers to establish technical specifications and to determine subject material to be developed.
Requirements:
  • Bachelor’s Degree, preferably in a Life Sciences or Engineering field (or equivalent work experience and education).
  • Minimum of 2 years of experience in technical writing with a biopharmaceutical manufacturing, validation, or quality control background (preferably in a cGMP setting).
  • Must be self-motivating, organized, and proactive, with a strong attention to detail Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Demonstrated experience with Standard Operating Procedures, Protocols, and Reports.
  • Ability to work hours necessary to support production and/or product transfer activities.
  • Intermediate to advanced computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
  • Knowledgeable in FDA GMPs (21 CFRs 210, 211, and/or 600) a plus.
Reporting Outline:
  • This position reports to the Director of Supply Chain & Facilities
  • Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.
Apply

Job Title: Senior Technical Sales Specialist
Reports to: Director of Sales
Role Description:

We are currently seeking a Senior Technical Sales Specialist to join the Forge Biologics team. This is an exciting opportunity to join and be instrumental to the growth of the organization. The individual chosen for this position must be a PhD level scientist and will provide technical expertise when interacting with current and potential clients. This role functions as a technical overlay for sales, focused on peer-to-peer conversations with technical leads at client organizations. This role can home-based, but must be willing to travel 30% to Forge Biologic’s corporate office in Columbus, Ohio

Responsibilities:
  • Provide a scientific perspective and acts as a technical interface between the Forge Biologics sales team and current or potential clients.
  • Oversee technical scoping of client engagements through the proposal and contract stages.
  • Work closely with the sales team to develop specific account growth strategies and assist in the effort to expand Forge’s sales through current and new business opportunities.
  • Demonstrates ability to build and sustain credible business relationships with customers and shares expertise accordingly.
  • Develops, leads and/or facilitates trainings or other programs to internal and external stakeholders
  • Handle multiple tasks in parallel and balance workload based on the priority of assignments
  • Attend and participate in industry events, trade shows, vendor shows, and other related events as needed
Requirements:
  • PhD in Biology or related field required
  • Hands on experience working in gene therapy, cell therapy or related field preferred
  • Experience in biologics or gene therapy CDMO required
  • Outstanding relationship management and influencing capabilities
  • Strong written and verbal communication skills
  • Demonstrates a business acumen and drive for results
  • Proficient in Microsoft Office and CRM tools
Apply

Job Title: Accounting Manager
Reports to: Vice President, Finance and Investor Relations
Role Description:

We are currently seeking an Accounting Manager to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing and therapeutics development company located in Columbus, Ohio. The candidate will work directly with the Vice President of Finance and Investor Relations as well as having direct exposure to the executive leadership team. The ideal candidate will have a strong working knowledge of how to manage the day-to-day activities of an accounting department. This person will help to ensure the internal accounting processes are in line with the overall goals of the company. This position requires someone who readily adapts to change, has experience with manufacturing operations, and is comfortable in a high growth startup environment.

Responsibilities:
  • Own month-end closing, account reconciliations, intercompany eliminations and consolidation.
  • Analyze accounts, records, payables, journal entries and general ledgers for support and accuracy.
  • Supervise staff handling procurement and payables processing.
  • Prepare monthly budget to actual variance reports
  • Assist with implementation of internal controls.
  • Assist with the external year-end audit, preparation of financial reports for the board of directors, lead and organize various ad-hoc projects
  • Preparation of client invoicing and financial tracking of client contracts
  • Assist with the documentation of necessary accounting policies to ensure compliance with US GAAP.
Requirements and Qualifications:
  • Bachelor’s Degree in accounting or finance, CPA required.
  • 5+ years of accounting experience, public accounting experience preferred Working knowledge of SOX and US GAAP.
  • Experience in working with Netsuite and QuickbooksOnline is a plus
  • Demonstrated initiative, highly detail oriented, multi-tasking and prioritization skills.
Apply

Job Title: Human Resources Director
Reports to: Vice President of Finance and Operations
Role Description:

We are currently seeking a Human Resources Director join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing company and to lead the development and implementation of people-related services, policies, and programs. The Human Resource Director will plan, lead, direct, develop, and coordinate the policies, activities, and staff of the Human Resource (HR) department, ensuring compliance and implementation of the organizations mission and talent strategy. The candidate will work directly with the Vice President of Finance and Operations as well as having direct exposure to the executive leadership team. The ideal candidate will have led Human Resources in practice and helped set objectives that will provide an employee-oriented, high-performance culture that emphasizes empowerment, quality, productivity, standards and goal attainment. This position requires someone who readily adapts to change and is comfortable with setting up HR structure in a high growth startup environment.

Responsibilities:
  • Be a trusted advisor and partner to leaders in identifying and building talent strategies within teams and across the company.
  • Contribute in developing programs and systems for a healthy organization.
  • Collaborate with cross functional partners to plan, lead, develop, and implement policies, processes, training and initiatives to support the organizations human resources strategy and compliance needs.
  • Develop and buildout consistent and seamless onboarding procedures for new employees.
  • Provide professional human resource coordination in a variety of areas to include training, safety, employee relations, benefits review and enrollment, compensation, unemployment and worker’s compensation.
  • Develops and delivers initiatives that help to reinforce culture that enables top talent to feel engaged, contribute, grow in their career and develop leadership skills.
  • Propose and lead HR initiatives, policies and programs including resolution of employee issues and conflicts.
  • Ensure the organization’s compliance with local, state, and federal regulations.
  • Counsel employees regarding benefit issues, eligibility for insurance, and coverage.
  • Develop and implement a department budget, as needed.
  • High degree of professionalism and confidentiality
  • Performs other duties as required.
Requirements and Qualifications:
  • 10+ years of progressive human resources experience.
  • Ability to create and implement sustainable HR solutions.
  • Advanced knowledge of HR policies, practices and employment law.
  • Experience in employee relations, performance management, and workplace accommodations a plus.
  • Experience with ADP WorkforceNow and Greenhouse a plus.
  • Possesses strong program management skills along with effective verbal and written communication skills.
  • Ability to coach and influence at any level withi the organization.
  • Excellent organizational skills and attention to detail.
  • Ability to adapt to the needs of the organization and it’s employees.
  • Bachelor’s degree in HR or related field
Apply

Job Title: Manager, Investor Relations
Reports to: Vice President, Finance and Investor Relations
Role Description:

We are currently seeking a Manager of Investor Relations to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing and therapeutics development company. The candidate will work directly with the Vice President of Finance and Investor Relations as well as having direct exposure to the executive leadership team. The ideal candidate will provide support of all investor relations activities in order to increase shareholder exposure to the company by effectively communicating company strategy, goals, business plans, and results. This position requires someone who readily adapts to change and is comfortable with setting up Investor Relations structure in a high growth environment.

Responsibilities:
  • Collaborate with the VP Finance/IR and Executive team members to assist/lead the creation of value-driver-based investment messages.
  • Monitor and report on market intelligence by tracking research reports, news, earnings results and material from other relevant sources
  • Develop detailed knowledge of value drivers for the company
  • Collaborate with the investor relations team to prepare quarterly board forecasts and budget updates, and investor selection/identification strategies
  • Support the design and execution of institutional investor targeting by supporting construction and execution of investor days, conferences, and analyst meetings and calls.
  • Monitor inbound investor inquiries and deliver efficient and responsive resolution to investor requests
  • Travel up to 30%
Requirements and Qualifications:
  • 4+ years in areas of equity research, investment banking, corporate finance or investor relations consulting
  • Bachelor’s Degree in finance or related field
  • A clear and thorough understanding of the financial modeling techniques used by security analysts to project a company’s operating and financial performance.
  • A good understanding of securities regulations and strategic communication
  • Ability to adhere to company policies and federal regulations regarding information disclosure
  • The preferred candidate will have experience with institutional financing and developed bank relationships
Apply

Job Title: Business Development Manager
Reports to: Vice President, Head of Business Development
Role Description:

We are currently seeking a Business Development Manager to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing and therapeutics development company located in Columbus, Ohio. The Business Development Manager will b responsible for the coordination of cross functional diligence efforts and the integration of licensed/acquired assets by partnering with the business development team. The Hiring Manager is in NYC and the position can be remote, but preferred on eastern time zone.

Responsibilities:
  • Bachelor’s degree in a relevant discipline and a minimum of 2-4 years of experience in related roles in consulting, pharmaceutical, biotechnology, finance or related environment OR 3-6 years equivalent combination of education and/or experience.
  • Requires a minimum of 2 years of experience in the biotechnology or pharmaceutical industry or related field.
  • Requires a minimum of 1-2 years of experience in a project management role.
  • Strong strategic and organizational abilities to manage cross-functional work streams.
  • Strong communication skills and demonstrated cross-functional collaboration to effectively coordinate evaluation and diligence teams.
  • Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
  • Proficiency with Microsoft platform
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Special knowledge or skills and/or licenses or certificates preferred
  • Experience in gene therapy/rare/orphan disease field preferred
  • Travel requirements: 20% including domestic and international travel.
Apply
Join

Connect

Fortis Fortuna Adiuvat

If you feel called to connect with us about working at Forge, but don’t see an exact fit in the above positions or feel you are qualified in a unique way, remember that fortune favors the bold. Contact us anyway at careers@forgebiologics.com.

5/5 (1 Review)