Our Global Gene Therapy client here in Cambridge, MA is looking to add a Principal Scientist, Analytical Development (Associate Director level) to their team! This role will lead the development and qualification of test methods and analytics supporting the manufacturing and release of cell-based products. Scientist will be responsible for both the strategic planning and day-to-day execution of specific projects, in collaboration with various stakeholders. Other responsibilities include but not limited to:
- Design and lead the execution and analysis of studies to develop and qualify test methods, demonstrate technological feasibility and characterize cell- based products, including safety, composition and potency.
- Manage and provide subject matter expertise to a team of scientists to support multiple cell-based programs
- Guide development of analytical program plans and their execution to meet strategic objectives
- Monitor and report on project progress, write analytical development protocols and reports, provide recommendations to senior management
- Identify, qualify and manage analytical reagents as per regulatory standards
- Establish design criteria using Design of Experiments (DOE) and other contemporary development tools
- Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
- Establish reference standard materials as required to support assay validation.
- Train and transfer assays to QC groups or third-party vendors.
- PhD in cell/molecular biology or related discipline with 8+ years of industry experience in assay / analytical development, plus 5 years management experience
- Deep practical knowledge of analytical development requirements, regulatory guidance
- Good understanding of statistical methods requirements for study design and data analysis
- Proven experience with the culture of multiple mammalian cell lines
- Ability to use literature to design proof of concept experiments for assays
- Demonstrated prior experience developing cell-based assays for the assessment of product composition and potency employing multiple analytical methods (ELISA, PCR, FC, etc.)
- Excellent organizational skills, technical writing, record-keeping and ability to manage multiple projects
- Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success
- Strong knowledge of GMP, GLP, ICH and other regulatory requirements for biological product characterization and release assay qualification.
- 3+ year of relevant industry experience in cell and gene therapy space
- Practical experience with managing and overseeing analytical activities at third party contract research organizations (CROs)
- Experience with IND filing in the analytical development space
- Strong background in pluripotent stem cells and directed differentiation
- Background in pancreatic islet biology, muscle biology