Contract - Sr. Research Associate, Analytical Development

Role:

This laboratory-based position is responsible for qualification, and execution of sample analysis using bioanalytical assays, primarily ELISA and MSD based assays, to support Be Bio’s R&D and research pipeline programs. This position will also have the scope of training on other assay types such as FACS and cell culture, to support other cross functional teams within the Be Bio organization.  

The successful candidate will utilize their knowledge of ELISA to apply these methods to execute assays, perform data analysis and present data to the internal teams. Prior experience in generating and maintaining test methods, assay worksheets, SOPs and R&D processes to GLP standards is desirable. This position has tremendous room for growth and opportunities across multiple areas of the R&D organization.

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.
• 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 1-2 years of industry experience.
• Hands-on experience with ELISA/ELIspot. Additional skills; cell culture, PCR, q-PCR, ddPCR, flow cytometry and cell-based functional assays preferred.
• 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.