Associate Scientist, Analytical Development

Job Title: Associate Scientist, Analytical Development

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 programs. You will be responsible for the development of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays 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:

• Performing product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for gene therapy product process development and manufacturing. These include, but may not be limited to DNA/RNA isolation, plasmid characterization, qPCR, ddPCR, ELISA, SDS-PAGE and Capillary Electrophoresis
• Compiling experimental data with minimal oversight, generating reports, and archiving assay data.
• Assist the gene therapy process development team in the analysis and interpretation of assay results.
• Support the analytical and process development group's daily operational needs by maintaining assay cell lines, 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 and a minimum of 1+ year(s) of relevant experience in a pharmaceutical, biotechnology or related environment or a Master’s degree in these same disciplines
• Proficiency with the conduct of qPCR and immunoassays is preferred
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is preferred
• Proficiency with Microsoft Office
• Excellent verbal 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
• Ability to work with a high attention to detail
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
• In our commitment to safety of our employees and customers a COVID vaccination and booster is required