Analytical Development Research Scientist
About The Position
The Analytical Development Research Scientist works independently to design and execute complex experimental procedures, troubleshoot challenges, and develop alternative approaches to achieve desired outcomes. The role involves strategic planning consistent with regulatory guidance, applying innovative approaches, maintaining technical expertise, and authoring and reviewing analytical method documents, study protocols, and reports. The scientist collaborates with the analytical development team and cross-functional groups to support CMC organizational goals. This hands-on position combines advanced data analytics with laboratory-based assay development for cell-based products.
Requirements
- Demonstrated experience applying data science and statistical analysis to complex scientific questions.
- Ability to independently plan and execute technical work, interpret results, and communicate conclusions to cross-functional audiences.
- Proficiency in advanced data analysis, statistical analysis (e.g., JMP, GraphPad Prism, and PLA analysis), data visualization, machine learning, and modeling.
- Strong analytical programming skills, including Python, R, SQL, and cloud platforms.
- Hands-on experience with at least one of the following: cell count and viability, cell cluster characterization, flow cytometry, or mammalian cell culture.
- Experience with assay development, qualification, troubleshooting, optimization, and performance trending.
- Experience with characterization and release testing for identity, purity, strength, and potency.
- Clear and effective communication abilities.
- Independent project leadership.
- Adherence to ethical data practices.
- Experience with ELN/LIMS systems.
- Experience authoring SOPs, protocols, and technical reports.
- Knowledge of FDA, ICH, and USP regulatory guidance for cell therapy and cell-based assay development.
- One of the following education and experience combinations: Ph.D. or equivalent and 0–3 years of relevant postdoctoral employment experience; master's degree or equivalent and 3+ years of relevant employment experience; or bachelor's degree or equivalent and 6+ years of relevant employment experience.
- Experience in an analytical development program, providing technical support in a manufacturing setting, or in a technical role in a QC environment.
- Experience designing and/or performing assay qualification, including authoring and/or reviewing relevant documentation.
Responsibilities
- Conceptualize, develop, and deploy analytical solutions to support characterization of cell-based products.
- Perform laboratory experiments for analytical method development for gene and cell therapy products, applying statistical analyses to assess specificity, sensitivity, linear range, precision, and accuracy.
- Analyze complex experimental and process data, create visualizations, and present findings and recommendations to technical teams and management.
- Execute test methods supporting Process Development activities and process improvements.
- Author and review SOPs, protocols, technical reports, and transfer and qualification documentation; contribute analytical content to regulatory filings.
- Maintain clear, accurate, and compliant records, including electronic lab notebooks and test forms.
- Stay current with developments in data science and apply relevant approaches to analytical challenges.
Benefits
- Annual bonus eligibility.
- Annual equity awards.
- Medical, dental, and vision benefits.
- Paid time off, including a week-long company shutdown in the summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy.
- Matching charitable donations.
- 401(k).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
