Associate Scientist, Analytical Development (Proteins)

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:

We are currently seeking an Associate Scientist I, Analytical Development (Proteins) to join the Forge Biologics team. This is an exciting opportunity to help drive the development of Forge Biologic’s in-house programs as well as client programs. As a member of the Proteins Analytical Development team, you will be responsible for the development of molecular assays including, but not limited to AUC, SEC-MALS, HPLC, ELISAs, protein and DNA gel electrophoresis, and mass spectrometry for capsid identity 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).

Responsibilities:

• Perform product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for process development and manufacturing. These include, but may not be limited to ELISA, SDS-PAGE, Western Blot, AUC, CE, SEC-MALS, HPLC, and mass spec.
• Compile experimental data with minimal oversight, generating reports, and archiving assay data.
• Assist the process development team in the analysis and interpretation of assay results.
• Support the analytical and process development group's daily operational needs by maintaining controls, standards, and reagent inventories.
• Apply relevant scientific principles and techniques to analytical development problems.
• Maintain detailed, up to date, and reviewed laboratory notebooks.

Requirements:

• Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline; Associate’s degree with 2 years of relevant experience may be considered
• Proficiency with the conduct of protein based assays is preferred
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is preferred.
• Proficiency with Microsoft Office Suite
• In our commitment to safety of our employees and customers a COVID vaccination and booster is required