South San Francisco, CA 94080 US
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.
- Develop assays for gene therapy products GMP release and characterization.
- 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
- Report project status (development plans, timelines, and results) to supervisor and technical teams.
- Write tech transfer and development reports.
- Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
- Maintain accurate, error-free records of all analytical development activities timely
- 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
- Strong knowledge of virus, protein and DNA/RNA chemistry
- 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)
- Success in transfer of qualified methodologies to QC consistent with project timelines and regulatory expectations.
- A clear and organized thought process, with attention to detail and a high-quality work ethic are essential.
- Proficient in Microsoft Office to include Excel, PowerPoint, Word
- Demonstrated verbal and written skills in technical reports and documents
- Positive, professional self-starter with a passion for science
- Proven ability to work collaboratively in a team environment as well as being an individual contributor
- 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
- 3+ years with HPLC usage and troubleshooting,
- Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics
- Prior AAV or Antivirus characterization
- Experience in statistical analysis using JMP or other software
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