Scientist, Assay Development Jobs

The Role

Reporting to the Associate Director, Analytical Development, the Principal RA/Scientist will be responsible for developing assays for the GMP release of drug substances and drug products, using HPLC, Capillary Electrophoresis, AUC and other analytical tools. The position level will be commensurate with education and experience level. This role will be at our South San Francisco location.

Primary Responsibilities

• Write tech transfer and development reports.
• Develop assays for AAV/protein/DNA using biophysical methods, such as HPLC, CE, AUC and Mass Spec to assist in evaluation of process change, formulation and stability study using statistical methods as needed, following SOPs and execute experiments according to guidelines
• Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
• Report project status (development plans, timelines, and results) to supervisor and technical teams.
• Develop assays for gene therapy products GMP release and characterization.
• Maintain accurate, error-free records of all analytical development activities timely

About you

Must Have/Required

• Success in transfer of qualified methodologies to QC consistent with project timelines and regulatory expectations.
• Proven ability to work collaboratively in a team environment as well as being an individual contributor
• Proficient in Microsoft Office to include Excel, PowerPoint, Word
• Strong knowledge of virus, protein and DNA/RNA chemistry
• Demonstrated verbal and written skills in technical reports and documents
• Positive, professional self-starter with a passion for science
• Bachelor of Science with 5+ years, or Master of Science with 3+ years, or PhD with 1+ years’ experience in biopharma industry with proven expertise of a range of physicochemical methodologies consistent with ICH guidelines for quantifying purity/quality of proteins, viruses, and viral vectors
• Extensive experience operating HPLC applied to DNA/RNA, protein and/or viral vectors, familiar with Waters HPLC or equivalent, experience with Empower software
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
• Prior history in compiling and analyzing data and generating reports which is routinely presented to project teams to enable decision making and writing for regulatory filings
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP)
• A clear and organized thought process, with attention to detail and a high-quality work ethic are essential.

May Have/Preferred

• Experience in statistical analysis using JMP or other software
• 3+ years with HPLC usage and troubleshooting,
• Prior AAV or Antivirus characterization
• Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics