contract - Sr./Research Associate, Analytical Development

Contract - Sr./Research Associate, Process Analytics, Analytical Development

Role: Be Biopharma is seeking a candidate for the Process Analytics sub-team in the Analytical Development (AD) department. AD is responsible for characterizing the B cell medicine, the expressed protein, and process impurities. There are three significant responsibilities within the Process Analytics sub-team, executing cell-based methods for characterizing the manufacturing process, development of in-process and fit for purpose methods, and capturing data in an electronic laboratory notebooks (ELN) and reports for traceability. Roles and responsibilities will be given based on experience and knowledge in the cell therapy analytical development field. This is an excellent opportunity for career growth as you would interact with various program teams and be involved in learning and executing a diverse number of methods.

Responsibilities:

• Executing, implementing, and documenting, routine characterization and release assays for identity, purity, strength, and potency (techniques may include cell counting, flow cytometry, ELISA/ELISpot, ddPCR, sequencing, etc).
• Develop in-process and fit for purpose methods for characterization of B cell medicine, the expressed protein, process impurities and metabolites.
• Support Process Development product characterization activities.
• Assist in pre-qualification of methods related to impurities (residual host DNA/protein, plasmids) associated with drug products.
• Manage analytical reagents inventory, including reference standard materials as per regulatory standards.
• Be a strong team player contributing to group priorities and deliverables.

Experience, Education, Specialized Knowledge, and Skills:

• BS or MS in Chemical Engineering, Biology, Analytical Chemistry, Biochemistry, Cell & Molecular Biology, or related discipline with 0-2 years of industry experience.
• Hands-on experience with cell culture, flow cytometry, ELISAs, and cell-based functional assays. Experience with PCR, qPCR, ddPCR is preferred but not required.
• Demonstrated understanding of developing analytical methods in compliance with ICH preferred but not required.
• Experience documenting procedural steps and results within an ELN system.
• Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented, and critical thinker.
• Ability to use literature to design proof of concept studies.