Director of Analytic Development and Quality Control (MA)

Job Description
Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapies, is seeking an outstanding Director of Analytic Development and Quality Control to join its growing team. The full-time role will provide strategic leadership and direction of complex scientific, engineering, or technical aspects of clinical materials production and release testing program(s) with responsibility for Quality Control (QC) Operations. Implement, evaluate and maintain all quality control standards applicable to a IND based production of candidate cell therapy products for Phase I/II clinical investigations. Achieve corporate goals through the management of staff and/or partners engaged in developing, advancing and applying science, engineering and technology. The position will be located in Cambridge, MA (Kendall Square).

Responsibilities:

  • Act as the Analytical project leader and provide scientific leadership in analytical design and methods development during process development and manufacturing activities
  • Recommend emerging technologies in the field of cell therapy. Identify and implement contemporary methods and technologies in support of SEMMA product development goals
  • Make recommendations about product characterization assay development as indicated in support of product development activities
  • Responsible for all Quality Control (QC) activities for SEMMA cell therapy products manufactured under IND including development and execution of in-process and release tests, environmental and personnel monitoring and overall quality oversight for Phase I & II Clinical Trials
  • Inform, drive and oversee all technical aspects related to Quality Control requirements for compliance with cGMP regulations; develop Quality Control programmatic direction related to analytical development and manufacturing for translational medicine conducted at the SEMMA
  • Act as the technical leader and persuasive liaison to external collaborators, contractors and other financial stakeholders ensuring continuous process excellence in quality checks and release criteria for clinical materials
  • Lead, oversee and approve release of all QC components of batch records
  • Manage staff including recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts
  • Implement, evaluate and maintain all quality control standards applicable to a IND based production of candidate cell therapy products for Phase I/II clinical investigations
  • Serve as a liaison to senior management, cross-functional areas and external organizations such as sponsors and government agencies
  • Draft Analytical components of Chemistry, Manufacturing & Controls portion of IND applications as needed. Act as the QC liaison for SEMMA with the FDA, with senior management as needed, in particular in communication with the external collaborators and contractors

Required qualifications:

  • Bachelor’s degree in Biological, Bioengineering, Chemical Engineering or process related sciences required. Advanced degree preferred
  • Extensive (>15 years) biological sciences experience required. Experience with iPSC cells and their derivatives (pancreatic islets) preferred
  • At least 10 years prior GMP Quality Control experience required. At least 5 years working in analytical development and/or QC release testing of cell therapy products preferred (sterility, mycoplasma, endotoxin, viability etc.)
  • Expertise in functional assays and cell-focused technologies for clinical materials assessment required. Experience with flow cytometry, histology, immunohistochemistry, insulin response assays preferred
  • Strong knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820) required

Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.

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