Scientist I, Analytical Development

Forge Biologics - Columbus, OH

Full-time - Mid Level

Columbus, OH

Administrative and Support Services

About the position

The Scientist I position in Analytical Development at Forge Biologics focuses on the development of cell-based AAV gene therapy potency assays. This role requires a strong background in cell culture and assay method development, with responsibilities including the design and optimization of various biological and molecular assays. The position emphasizes collaboration with cross-functional teams and adherence to regulatory requirements, ensuring timely communication of results and documentation.

Responsibilities

• Design and execute cell bioanalytical assays to support manufacturing, purification, and clinical comparability of AAV gene therapy products.
• Evaluate cell culture models for use in potency assays for multiple new gene therapy programs.
• Perform cell-based assays to assess the in vitro potency of novel AAV gene therapy drug products.
• Ability to perform or learn other analytical assays such as RT-qPCR, ddPCR, ELISA, Flow Cytometry, and Western Blot.
• Work seamlessly with cross-functional stakeholders including Process Development, Product Development, and Quality Control to help advance the AAV vector production portfolios.
• Create and maintain clear and concise lab records and documentation.
• Author study plans, development reports, and method protocols in accordance with ICH and USP guidance.
• Maintain a 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.

Requirements

• PhD in Molecular Biology, Biotechnology, Biochemistry, Immunology, Virology, or a related field with 0-2+ years 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.
• 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 desirable.
• Experience with ddPCR, ELISA, SDS-PAGE, and Western Blot is desirable.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• 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.

Nice-to-haves

• 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 desirable.

Benefits

• Paid parental leave
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Financial planning services
• Paid time off
• Parental leave
• Snacks provided
• Employee assistance program
• Vision insurance
• 401(k) matching
• Employee discount
• Food provided