Sr. Associate Scientist, Drug Substance-Data Science (Contract)
$93,600–$104,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Conduct Cell Starting Material characterization studies using QbD principles to support process understanding and optimization. Apply advanced statistical tools to large datasets for raw materials and product analysis, and support clinical-scale non-GMP manufacturing for BLA-enabling process characterization. Contribute to continuous improvement initiatives by evaluating process parameters, materials, and operational workflows while ensuring high-quality documentation in electronic laboratory notebooks and technical reports. Present data and strategy to scientists and management in internal venues, and collaborate effectively with Project Technical Teams and all stakeholder groups. Maintain currency with relevant cell therapy, immunology, and bioprocessing literature.
Required Qualifications
- BS/MS in Molecular & Cell Biology, Immunology
- MS plus at least 2 years of experience or BS with at least 5 years experience
- demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology
- Ability to work in a fast-paced, startup environment
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication
- Candidates must be authorized to work in the U.S.
Desired Qualifications
- BS/MS in Molecular & Cell Biology, Immunology with emphasis on data science preferred
- Experience in Quality by Desing methodologies and statistical modeling in biologics or cell therapy space is highly preferred
- Experienced with multivariate data analysis, preferred experience with statistical software (JMP, R-Studio, Python)
- Designed and deployed dashboards for real-time process monitoring, improving data accessibility and decision-making capabilities
- Experience in flow cytometry is highly preferred
- Experience with prior Gene & Cell Therapy manufacturing preferred but not required
- Experience in genetic modification of cells using gene editing and gene delivery technologies preferred but not required
- Experience with PBMC isolation techniques preferred but not required
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.