Analytical Development Research Scientist
About The Position
The Analytical Development Research Scientist works with a high degree of independence to design and execute complex experiments within required timelines. The role involves resourceful, self-sufficient work, troubleshooting, and developing alternative approaches to achieve desired outcomes. The scientist performs strategic planning consistent with regulatory guidance, applies innovative approaches, and maintains strong technical knowledge. This hands-on position combines advanced data analytics with laboratory-based assay development in a cross-functional setting. The scientist develops analytical solutions to characterize cell-based products, performs analytical method development for gene and cell therapy products, and analyzes experimental and process data. The role also supports Process Development activities, authors and reviews technical and regulatory documentation, and collaborates across teams to meet CMC organizational goals.
Requirements
- Ph.D. or equivalent degree and 0–3 years of relevant post-doctoral employment experience; or a master's degree or equivalent and 3+ years of relevant employment experience; or a 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 working in a technical role in a QC environment.
- Experience designing and/or performing assay qualification, including authoring and/or reviewing relevant documentation.
- 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, 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.
- Knowledge and experience in 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 and independent project leadership.
- Adherence to ethical data practices.
- Experience with ELN/LIMS systems.
- Knowledge of regulatory guidance for cell therapy and cell-based assay development from FDA, ICH, and USP.
Responsibilities
- Independently conceptualize, develop, and deploy analytical solutions to support characterization of cell-based products.
- Perform laboratory experiments supporting analytical method development for gene and cell therapy products.
- Apply statistical analyses to assess assay 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 the broader data science community and apply relevant approaches to analytical challenges.
- Collaborate within the analytical development team and cross-functionally with other groups to meet CMC organizational goals.
Benefits
- Annual bonus eligibility
- Annual equity awards
- Medical benefits
- Dental benefits
- Vision benefits
- Generous 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)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
