(Sr) Scientist, Cell Therapy Technology Transfer Lead (MA)

Job Description
Semma Therapeutics, a recently founded biotechnology company focused on develoSemma Therapeutics, a biotechnology company focused on developing stem cell-based cell therapies, is seeking an outstanding Scientist/Sr Scientist, Cell Therapy Technology Transfer Lead, to join its growing team. The full-time role will be part of the Cell Therapy R&D team and will be responsible for leading the technology transfer of cell therapy manufacturing processes from R&D to Semma’s clinical production Manufacturing team. The position will be located in Cambridge, MA (Kendall Square).

Responsibilities:

  • Leads technology transfer of cell manufacturing process and associated analytical testing from R&D to Semma’s internal Manufacturing group and/or CMOs
  • Develops deep process expertise through working closely with Subject Matter Experts and performing data analysis
  • Coordinates cross-functionally with R&D, Quality, Manufacturing, and Operations departments
  • Authors and reviews technical protocols and reports, qualification protocols and reports, Standard Operating Procedures (SOPs), and Master Batch Records for manufacturing cell therapy products
  • Provides input to Operations and Manufacturing to ensure all necessary raw materials and equipment have been sourced
  • Contributes to risk and gap assessments for new and existing process, equipment, materials and resources
  • Develops and oversees schedule and training plan and tech transfer protocol for training manufacturing operators and executing pilot production runs
  • Collaborates with Associate Director of Clinical Materials Production and other Manufacturing, Quality and R&D leadership to ensure successful completion of initial technology transfer and transfer of process improvements throughout product development lifecycle
  • Provides regular tech transfer status updates to all stakeholders (Manufacturing, R&D, Quality and Operations) and proactively identifies and addresses risks to milestones and timelines
  • Other duties and projects as assigned

Required qualifications:

  • Master’s degree in Biological, Bioengineering, Chemical Engineering or process related sciences required. (PhD preferred.)
  • At least 3 years prior cell or biologics manufacturing, process development or technology transfer experience required
  • Highly organized with demonstrated capacity to manage multiple workstreams and to collaborate cross-functionally

Preferred qualifications:

  • Expertise in cell processing and culture technologies for GMP manufacturing
  • Experience with 3 to 15-liter scale bioreactors for cell culture
  • Experience with stem cells and their derivatives preferred
  • Some familiarity with federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820) and desire to learn

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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