Senior Analytical Development Scientist – Biologics

Avid Bioservices, Inc.; Tustin (CA); On-site; USD 84,000 - 105,000; Full time

Job summary

Avid Bioservices, Inc. in California is seeking aSenior Research Associate for Analytical Development to advance cell-based, ELISA, HPLC, CE and SDS-PAGE methods.

You will collaborate with analytical and process development teams to characterize protein biologics and transfer methods to QC for cGMP testing. Ideal candidates have 4+ years in QC/analytical labs (BS) or 2+ years with MS, with GMP exposure, assay development, and strong writing skills.

Qualifications

• 4+ years in a QC or analytical lab with BS in Biochemistry, Chemistry, Biology or pharmaceutical sciences.
• 2+ years in a QC or analytical lab with MS degree.
• Experience with analytical testing and equipment used in biochemistry.
• Experience writing reports, procedures and specifications.
• GMPs and regulatory audit experience.
• Potency/ELISA and/or HPLC experience is essential.
• Familiarity with protein characterization, electrophoresis, chromatography and assay-validation.

Responsibilities

• Perform and review routine wet chemistry assays and ELISA/cell-based immunoassays, SDS-PAGE/IEF and HPLC.
• May train or supervise junior analysts and participate in tech transfer teams.
• Develop, review, revise and write test methods and SOPs; perform trending analysis.
• Lead studies for validation projects, investigations, and method development.
• Interface with Quality Control and external clients as needed.
• Support regulatory inspections and continuous improvement initiatives.

Job description

Avid Bioservices, Inc. in California is seeking aSenior Research Associate for Analytical Development to advance cell-based, ELISA, HPLC, CE and SDS-PAGE methods.

You will collaborate with analytical and process development teams to characterize protein biologics and transfer methods to QC for cGMP testing. Ideal candidates have 4+ years in QC/analytical labs (BS) or 2+ years with MS, with GMP exposure, assay development, and strong writing skills.