Our Boston based biotechnology client is seeking a highly skilled Senior or Principal Scientist to lead the development, transfer, and validation of bioassay methods supporting innovative gene therapy programs. This role is ideal for a scientifically driven professional who thrives in a dynamic, collaborative environment and is motivated by impactful work in clinical-stage development. This position requires 2-3 days per week onsite in Boston, MA.
About the Role
The incumbent will be responsible for establishing and managing biological potency assays used for release and stability testing. This position also oversees CRO activities for both GMP and non-GMP sample testing, ensuring high-quality execution and regulatory compliance.
You will collaborate closely with cross-functional teams, contribute to analytical CMC documentation, and support regulatory submissions. This is a high-impact role with opportunities to influence analytical strategy and drive scientific excellence.
Key Responsibilities
- Lead development, transfer, and validation of biological assays for release and stability testing.
- Manage laboratory investigations, OOS assessments, and data trending; support manufacturing investigations.
- Execute development studies for process and product characterization, including comparability assessments.
- Draft, review, and approve SOPs, protocols, reports, and analytical documentation for internal and external QC labs.
- Support preparation of analytical CMC content for regulatory submissions, including data summaries and trend analyses.
- Collaborate effectively with internal stakeholders and manage external CRO relationships.
Skills and Expertise
- Strong technical expertise and hands-on experience with cell-based potency assays.
- Familiarity with statistical analysis tools (e.g., JMP, Prism, PLA 3.0) is an asset.
- Excellent technical writing skills for analytical CMC documents, including change controls, SOPs, protocols, and reports.
- Solid understanding of regulatory guidance and GMP requirements for analytical method lifecycle management.
- Highly organized, detail-oriented, and capable of strategic thinking.
- Strong teamwork, communication, and collaboration skills.
Required Qualifications
- MS or PhD in Biological Sciences or related field, with a minimum of 10 years of biotech/pharma industry experience.
- Extensive hands-on experience in analytical method development, validation, and clinical-stage sample testing.
- Strong background in analytical documentation within a regulated environment.
- Proficiency in cell-based assays, ddPCR, and ELISA is required.
- Experience with HPLC/UPLC or CE-SDS is a plus.
- Demonstrated project management, problem-solving, and organizational skills.
- Experience managing CDMO/CRO partnerships is required.
- Excellent written and verbal communication skills, with the ability to present findings to diverse stakeholders.
