Contract - Sr. Research Associate, Analytical Development

Role:

Be Biopharma is seeking a contract Sr. Research Associate candidate to join the growing Analytical Development (AD) department. AD is responsible for establishing molecular, cell-based, and impurities methods used to characterize B cell drug products as well starting materials (ie AAV vector). The Sr. / Research Associate will be tasked with leading / supporting the different stages of assay development, feasibility, robustness, and prequalification. This is an excellent opportunity for career growth as you would interact with various programs teams and be involved in regulatory document preparation.

Responsibilities:

• Executing, implementing, and documenting, characterization and release assays for identity, purity, strength, and potency (techniques may include cell counting, flow cytometry, ELISA/ELIspot, ddPCR, sequencing, etc)
• Support Process Development product characterization activities.
• Assist in pre-qualification of methods related to impurity (residual host DNA/protein, plasmids) associated with drug products and AAV.
• Execute the assay design criteria using Design of Experiments (DOE).
• Perform method qualification to establish test methods' specificity, sensitivity, linear range, precision, and accuracy.
• Manage analytical reagents inventory, including reference standard materials as per regulatory standards.
• Assist in development and life cycle management of all training procedures for users to ensure the smooth operation of the test method.
• Be a strong team player contributing to group priorities and deliverables.
• As needed, provide routine analytical testing for stability and drug substance samples in support of in-house R&D and Process Development activities.

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, PCR, q-PCR, ddPCR, flow cytometry and cell-based functional assays.
• Demonstrated understanding of developing analytical methods in compliance with ICH preferred but not required.
• Experience in writing technical documents including development technical reports, qualification protocols and qualification reports preferred but not required.
• 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.