This position resides within the Genomic Medicine Unit (GMU), a part of our CMC Development organization. The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different cell and gene therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.
We are looking for a skilled and highly motivated scientist with broad expertise in immunophenotyping and cell sorting method development to join the GMU Analytical Development group in Framingham MA.
The primary accountability is to develop immunophenotyping and cell sorting methods, cGMP testing, and validation activities. In addition, the GMU Flow Cytometryteam will be responsible for introducing new technologies and ways of working to enable rapid progression of various early stage cell and gene therapy candidates into the clinic. The lab will be moving from Framingham to Waltham, MA in about a year.
- Develop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testing.
- Evaluate and implement new technologies within the Analytical Development department, with an emphasis on state-of-the-art immunophenotyping and cell sorting assays.
- Plan, prioritize, and execute simple and complex experiments with the relevant controls, independently.
- Troubleshoot existing protocols to increase method performance, throughput, and ergonomic control.
- Write analytical sections of IND/IMPD filings.
- May represents analytical development in cross functional meetings for projects and analytical initiatives.
- Work in a cGMP-compliant laboratory environment and ensure departmental SOPs, internal company standards and applicable regulations are consistently followed.
- Leads internal and external assay transfers consistent with established company procedures.
- May provide technical oversight and manage the workload for a few junior analysts.
- Ph.D. in Biology/Biochemistry or related discipline or Master’s degree with a minimum of 4 years of relevant industry experience, or a Bachelor’s Degree with a minimum of 6 years of relevant industry experience.
- Strong background in immunophenotyping and cell sorting methods (including familiarity with equipment from different vendors), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches.
- Experience with transferring methods between groups, preferably in a cGMP environment.
- Self-motivated with excellent organization, time-management, and communication skills.
- Innovative, critical and creative thinker, not afraid to propose disruptive solutions.
- Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g. invalid result investigations, deviations, and CAPAs)
- Experience with validation and transfer analytical methods.
- Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization.