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Manufacturing Operations Specialist

Company: Vertex Pharmaceuticals Inc (US)
Location: Cambridge
Posted on: May 3, 2021

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Vertex Cell and Genetic Therapies (VCGT) is designed to accelerate our progress in bringing multiple new transformative medicines to patients in need. We are seeking an outstanding Specialist to join our fast-paced and growing team. This full-time, individual contributor role will be responsible for the technology transfer and production of cell therapy products to support VCGT’s Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA).

Responsibilities:

  • Perform product manufacturing for clinical materials according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, reporting deviations.
  • Participates and facilitates technology transfer and final process development from the Research to the Manufacturing group. Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups
  • Ensures raw materials are identified and available in time for manufacturing activities
  • Supports Operations group to ensure proper coordination of resources
  • Ensures cGMP compliance through consistent execution
  • Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
  • Other duties and projects as assign as required to meet departmental requirements

Requirements:

  • Bachelor’s degree with 1-4 years in a process related science with some cell culture experience or an Associate’s degree with extensive cell culture experience required
  • Expertise in cell processing and culture technologies for clinical materials production required
  • Basic computer skills
  • At least 6 months working in process development and/or manufacturing of cell therapy products preferred
  • Experience with 3-15 liter scale bioreactors for cell culture preferred
  • Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
  • Experience with embryonic or induced pluripotent stem cell culture
  • Prior GMP manufacturing experience, preferably in a cleanroom environment

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Keywords: Vertex Pharmaceuticals Inc (US), Cambridge , Manufacturing Operations Specialist, Other , Cambridge, Massachusetts

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