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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: Director of Client Relations

We are currently seeking a Direct of Client Relations to join the Forge Biologics team. This is an exciting opportunity to join a high growth gene therapy manufacturing company to help support new and existing clients. The candidate will work directly with the VP, Marketing and Sales and the Communications team to advance Forge’s internal and external business strategy. The ideal candidate will serve as a liaison with clients - developing long-term relationships, providing guidance and advice, and ensuring all customer’s needs are being met.

Responsibilities:
  • Develop strong relationships with clients and support the expansion of existing clients
  • Develop regular reporting metrics to executive level business team including new client conversion, manufacturing capacity and overall process development for clients
  • Implement and maintain a CRM with accurate data while communicating with the finance teams to ensure proper forecasting and accounting
  • Develop and execute strategic growth plans to increase client awareness, recruitment and satisfaction.
  • Accurately develop new client strategies, program management and pipeline metrics
  • Built and achieve monthly, quarterly and annual client updates and budget goals for the client relations team in accordance with the company initiatives and vision
  • Manage the full sales cycle with the manufacturing team to ensure appropriate communication, successful service delivery and client retention
  • Attend trade shows and conferences and participate in relevant industry group events
  • Effectively hire, train and develop a client relations team while maintaining our corporate culture
  • Assist with the implementation of quality systems to ensure procedures meet or exceed client expectations
Requirements:
  • Bachelor’s degree preferably in a health related field
  • 6-8 years of experience with a proven track record, experience in the pharmaceutical, biotech or CDMO industries is preferred, with expertise in gene/cell therapy a plus
  • At least 3 years of experience in a client-focused position, including program management
  • Exceptional interpersonal, networking, collaboration, communication and cultural skills and awareness
  • Passion for creating experience and excellence in achieving results
  • Ability to flourish with minimal guidance, be proactive, and handle uncertainty and ambiguity.
  • Ability to manage multiple complex projects with excellent organization skills.
  • Familiarity with CRM software and systems
Apply

Job Title: Scientist, Product Development

Forge Biologics is seeking a Scientist to join the Product Development team. This is an exciting opportunity to contribute to the development of novel gene therapies aimed at treating patients with genetic diseases. The candidate will be responsible for assay development and molecular biology lab management and will work with cross-functional teams to complete projects. The Scientist will be a key contributor across multiple portfolio programs and will be integral to the success of the development pipeline.

Responsibilities:
  • Independently design and perform experiments, organize data, analyze results, including study reports
  • Clearly and effectively communicate methods, results, and conclusions to management
  • Design, develop and implement protocols, methodology and SOPs
  • Cloning, construction, and assessment of DNA constructs, including primer design
  • 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, cell transfection, qPCR, RT-qPCR, ddPCR, ELISA, ELIspot, SDS-PAGE and Western Blot
  • Perform AAV infectivity titration and neutralization assays, cell-based potency, and other functional bioassays
  • Work seamlessly with cross functional stakeholders including Process Development, Product Development, Regulatory and QA to help advance the therapeutic portfolio
  • Ensure that scientific and technical challenges are resolved in a timely manner
  • Manage externally contracted research efforts or collaborations as needed
  • Author nonclinical reports and summaries for regulatory submissions or manuscripts for peer-reviewed publications
  • Contribute to a safe, efficient, and effective environment with personal accountability
  • Travel on an infrequent basis is required (<10%) to support job responsibilities and commitments.
A successful candidate will have:
  • Degree in Molecular Biology, Biotechnology, Biochemistry, Immunology, Virology, or a related field
  • Ph.D. with 0-2+ or MS with 6+ years of related experience in method development and analysis using molecular biology techniques
  • Experience with aseptic techniques and mammalian cell culture and qPCR
  • Working experience in gene therapy and/or viral vector biology and mammalian gene expression is desirable
  • Experience designing and managing IND-enabling efficacy and toxicology studies
  • Excellent written and verbal communication skills
  • Creative, flexibility, and ability to work in a fast-paced small company setting
  • Detail oriented, ability to prioritize tasks and adhere to deadlines
  • Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
Apply

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
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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.

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