Massachusetts Green Jobs

Job Summary: We are looking for a skilled and highly motivated scientist with broad expertise in immunophenotyping and cell sorting method development to join our group in Framingham, MA. We have 1st and 2nd shift positions available. The primary accountability is to perform and develop flow-based analytical methods, cGMP testing, and validation activities. In addition, our team will be responsible for introducing new technologies and ways of working to enable the rapid progression of various early-stage cell and gene therapy candidates into the clinic. Job Responsibilities: Performs all activities in accordance with cGMP requirements and reports discrepancies.? Initiates and completes laboratory discrepancy events within expected timelines Provide and supervise analytical support for manufacturing operations, including qualification of in-process and release methods and assist in tech transfer internally and externally in support of GMP manufacturing and release of clinical material. Acquire a working knowledge of flow cytometry for routine testing, method validation and method transfer process Documents testing activities and results, ensuring completeness and accuracy per cGMP Contributes toward the development, revision, application, maintenance, validation and review of method SOPs.? Initiates and follows up on change request for SOP revision. Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings. Perform assay training and supports qualification of junior analysts Provide technical oversight and manage the workload for a few junior analysts ?Requirements: Ph.D. in Molecular Biology/Biochemistry/Biology or related discipline or master?s degree with a minimum of four years of relevant industry experience, or a bachelor?s degree with a minimum of six years of relevant industry experience Previous working experience in aseptic techniques and in flow cytometry Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g., invalid result investigations, deviations, and CAPAs) Experience leading a small team Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation Desired Skills: Experience authoring SOPs? Experience with transferring methods between groups in a cGMP environment Experience with validation and transfer analytical methods Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies. Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization