Scientist, Analytical Development

Company Overview: 

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Job Overview:

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).

Responsibilities:

• 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
• Write and review formal reports, including method SOPs, reports, and other technical documents
• 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
• Lead, mentor, and inspire junior team member

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 with ddPCR, ELISA, SDS-PAGE and Western Blot (preferred)
• Experience in gene therapy and/or vaccine testing (preferred)
• Prior experience performing viral genome titer, infectivity, potency, host cell protein, and host cell DNA assays (preferred)
• Experience with ddPCR, ELISA, SDS-PAGE and Western Blot (preferred)
• Knowledge of analytical ultracentrifugation techniques (preferred)
• In our commitment to safety of our employees and customers a COVID vaccination is required.