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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: Director, Research and Development

We are currently seeking a Director of Research and Development to join the Forge Biologics team. This is an exciting opportunity to provide leadership and oversight of internally developed and/or externally sourced gene therapy programs. The candidate will lead a team of skilled technicians and scientists to conduct research utilizing AAV Vectors. 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 Director, Research and Development will be responsible for gene therapy research and development and laboratory management at Forge. This includes assay development, product stability analysis, laboratory oversight, and pre-clinical study management formultiple programs.

Responsibilities include:
  • Independently design and perform experiments, organize data, analyze results, and be able to communicate to broader cross-functional teams
  • Establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data, author technical reports, and communicate results
  • Utilize cellular and molecular biological techniques such as PCR and RT-PCR, tissue culture, ELISA, DNA isolation and purification, restriction enzyme digestion, cloning and constructing recombinant plasmids and adeno-associated viral vectors (AAV)
  • Grow, purify and characterize adeno-associated viral vectors (AAV) for in vitro and in vivo testing
  • Write and update laboratory Standard Operating Procedures (SOPs), research primaryliterature, assemble research posters and write scientific lab reports
  • Compose manuscripts for peer-reviewed publications, chapters for books, reviews of peer publications and grant submissions
  • Development of clinical drug product testing, stability, storage, and site distribution
  • Design and oversee pre-clinical studies for drug product evaluation
The Ideal Candidate:
  • An advanced degree in a science-related discipline plus 3-5 years of experience in an industry setting is preferred
  • Strong experience in molecular biology and/or pharmaceutical development
  • Creative, flexibility, and ability to work in a fast-paced small company setting
  • Detail oriented, ability to prioritize tasks and adhere to deadlines
  • At least 3 distinct examples where meaningful excellence was achieved
  • Background in viral gene therapy, particular adeno-associated viral vectors (AAV)
  • Experience in organizing, summarizing, and communicating scientific results through publication or engagement with teams
  • Experience in developing potency assays
  • Preferred candidate will have experience under 21 CFR 58
  • Experience negotiating or managing contracts with contract vendors
  • Designing, drafting/organizing/completing pre-clinical animal protocols
  • Demonstrated project management, problem-solving and leadership abilities
  • Technical writing for regulatory and peer-reviewed submissions
  • Must be self-motivating, organized and proactive in order to coordinate the multi-departmental tasks and deliverables to a vertically dynamic audience
  • 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 10-20%) to support job responsibilities and commitments
Apply

Job Title: Manager, Quality Assurance

We are currently seeking a Quality Assurance (QA) Manager to join the Forge Biologics team. This is an exciting opportunity to provide leadership and oversight for our client led programs and in-house manufacturing. The candidate will lead the execution of the quality management system in close cooperation with operations and regulatory as well as provide support for coordinating execution of activities and/or audits. The ideal candidate will be skilled in system development and organization, cGMP documentation, and developing quality assurance guidelines to support our growth in the Gene Therapy sector. The candidate must possess strong organizational skills and a demonstrated ability to be self-directed while managing multiple projects. The candidate needs to establish leadership behaviors that build and foster trust, respect, cooperation, and collaboration across the organization.

Responsibilities include:
  • Provide day to day support for coordinating execution of activities and/or audits according to timelines
  • Lead and host client/agency audits on-site
  • Enforce compliance principles across groups to ensure quality of products and processes
  • Review and provide signatory review/approval of GMP documentation
  • Establish SOPs, policies, and guidelines in compliance with cGMP standards
  • Support collaboration with colleagues both within and outside of the department
  • Remain familiar with FDA and EMA policies to support projects in the US and ROW
  • Execute CAPA investigations and perform risk assessments where applicable
  • Identify and assure compliance with a training program suitable for all team functions
  • Communicate effectively to facilitate project or workflow efficiency and/or distribute information
  • Coordinate activities and tasks in a high through-put and high-quality environment
  • Work directly with the Director of QA to assure process communications are occurring in a timely manner and project budget and timelines are being adhered to
  • Work in close corporation with our customers and internal functions such as quality control, operations, warehousing, and facilities
  • Assist business development activities including vendor selection and screening
Requirements:
  • Bachelors or Master’s Degree in biologic sciences (or equivalent work experience)
  • Minimum of 6+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
  • Minimum of 3+ years’ experience in leadership/management/supervision in quality and/or logistics, with a preference toward direct Gene Therapy industry experience
  • Effective listening and coaching skills
  • Strong attention to detail
  • Strong knowledge in the following system(s): Quality Control, Quality Assurance, FDA/ISO regulations and process improvement/design via Lean and Six Sigma methodologies
  • Must be self-motivated, organized and proactive in order to coordinate the multi-departmental tasks and deliverables to a vertically dynamic audience (interaction with clients, PD, Eng., QA, QC, etc.)
  • Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
  • Ability to work hours necessary to support production and/or support 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
  • Remote working arrangements are available for this position when lab work is not required
  • Travel on an infrequent basis is required (less than 5%) to support job responsibilities and commitments
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: Director/Sr. Director, Quality Control

We are currently seeking a Director/Sr. Director of Quality Control to join the Forge Biologics team. This is an exciting opportunity to provide leadership and oversight of (pre-clinical/GMP) Quality Control. The candidate will lead a team of skilled technicians and scientists to test and characterize research, toxicology, and GMP grade AAV Vectors. The ideal candidate will be an expert in analytics and developing interdepartmental/interorganizational relationships to support our growth in the Gene Therapy sector.

The Director/ Sr. Director of Quality Control will oversee efforts to test research, toxicology, and GMP grade viral vectors that support clients’ pre-clinical and clinical efforts. Additionally, the Director/ Sr. Director will be responsible for working with the Director of Development to receive tech transfer of procedures for analytical applications, method development, qualification & suitability.

The Director/ Sr. Director of Quality Control will be responsible for establishing and qualifying analytical methods with the goal of validating assays for internal and external use. The Director/ Sr. Director will also analyze and report in-process and release testing data. Additional responsibilities include, design and support of stability programs. Lastly, the Director will oversee the release and distribution of product to client.

The individual chosen for this position will work in close partnership with manufacturing leadership, and/or external parties to support GMP manufacturing of clinical drugs. Duties also include, testing of master and working cell banks necessary to support process development and clinical manufacturing. The Director will also work closely with the Director of Process 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 AAV manufacturing platform process 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/ Sr. Director of Quality Control will keep current on regulatory requirements that may have an impact on the company’s development and testing plans.

Responsibilities:
  • Leads Quality Control activities from qualification of master cell banks to fill finish processes that incorporates application of GMP principles and methodologies to drive process enhancement and continuity between groups.
  • Driving the entire effort of drafting and revising assay documents, facility/equipment modeling, raw material estimates, testing records and sampling plans.
  • Works directly with the operations leadership to assure process communications are occurring in a timely manner and project budget and timeline are being adhered to.
  • Leads 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.
  • Prepares and presents data associated with quality control activities to clients.
  • Coordination of team activities, and scheduling of personnel & operations with other area managers.
  • Ensuring that operations adhere to the plant schedule and critical activities are always performed within the allotted timeframes.
  • Supports business development activities including vendor and contract manufacturer 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.
  • Additional responsibilities not listed may be assigned as needed by leadership.
Requirements:
  • Bachelors/Master’s Degree in biologic sciences (or equivalent work experience) with a minimum of 8+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
  • OR
  • Ph.D. biologic sciences with a minimum of 5+ years’ experience in biopharmaceutical manufacturing/Research and Development activities preferred
  • Minimum of 4+ years’ experience in leadership/management/supervision in Manufacturing and/or Process Engineering, with a preference toward direct Gene Therapy industry experience
  • Strong knowledge in the following system(s): Cell Culture, Pharmaceutical Utilities, Purification, Filling, Bioreactors, Automation, Process Sterilization, and Liquid Filling/Packaging. Driver for process improvement/design via Lean and Six Sigma methodologies
  • Must be self-motivating, organized and proactive in order to coordinate the multi-departmental tasks and deliverables to a vertically dynamic audience
  • 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
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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.