Analytical Development Scientist - Bioassay
About The Position
We’re seeking a skilled Analytical Development Scientist to join a client team dedicated to ensuring the consistency, safety, and efficacy of biologic therapies, including innovative cell and gene treatments. This role will specifically support the iPSC-induced islet cell therapy program within the Analytical Development Bioassay Team. The scientist will work closely with bioprocessing, formulation, and data science groups to support manufacturing and quality control across the development pipeline. Key responsibilities include: Design and execute bioanalytical assays including flow cytometry, cell counting, dPCR/qPCR, ELISA, and cell-based bioassays. Perform routine sample testing for in-process testing and lot release. Optimize assay parameters (specificity, sensitivity, precision, accuracy, linearity, etc.). Support assay qualification and lifecycle management. Document experiments and protocols using electronic lab notebooks (e.g., Benchling). Troubleshoot assay and instrument issues. Collaborate cross-functionally with Process Development, R&D, and Quality teams. Author technical documentation: protocols, test methods, reports, SOPs.
Requirements
- B.S. in Biology or related field with 3–4 years of experience in drug development labs, or M.S. with 1–2 years of experience.
- Hands-on experience with bioanalytical methods, including multi-color flow cytometry (minimum 4–6 colors preferred).
- Proficiency in mammalian cell culture techniques.
- Strong ability to troubleshoot, interpret data, and present conclusions effectively.
- Flexibility to take on additional responsibilities, including occasional weekend work.
Nice To Haves
- Experience with dPCR/qPCR and cell-based bioassays (e.g., glucose-stimulated insulin release, ELISA, live-cell plate assays).
- Demonstrated ability to increase assay throughput using multi-color flow cytometry, automated liquid handlers (e.g., Hamilton), and plate-based sample prep.
- Direct experience with iPSC differentiation and handling iPSC-derived cells.
- Proficiency in method development and qualification.
- Skilled in data analysis tools (e.g., GraphPad Prism, FlowJo) and digital platforms (e.g., Benchling, SharePoint, Veeva).
- Strong troubleshooting and continuous improvement mindset.
- Knowledge of regulatory standards and ICH guidelines.
- Excellent time management and organizational skills, with the ability to balance multiple priorities under tight deadlines.
- Clear and effective communication skills, with the ability to work independently and thrive in a collaborative, matrixed environment.
Responsibilities
- Design and execute bioanalytical assays including flow cytometry, cell counting, dPCR/qPCR, ELISA, and cell-based bioassays.
- Perform routine sample testing for in-process testing and lot release.
- Optimize assay parameters (specificity, sensitivity, precision, accuracy, linearity, etc.).
- Support assay qualification and lifecycle management.
- Document experiments and protocols using electronic lab notebooks (e.g., Benchling).
- Troubleshoot assay and instrument issues.
- Collaborate cross-functionally with Process Development, R&D, and Quality teams.
- Author technical documentation: protocols, test methods, reports, SOPs.
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
