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Head of Vector GMP Operations
at Vertex Pharmaceuticals
Boston, MA

Head of Vector GMP Operations
at Vertex Pharmaceuticals
Boston, MA

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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.

Position Description:

The Head of Vertex Vector GMP Operations will be responsible for the overall operational management of the Genetic Therapy Vector GMP Manufacturing Facility being designed and constructed in 2020. The Director will participate in the detailed design of the facility, specify equipment, and develop operational procedures. The Director will build a trained team of operators and engineers to support transfer of new processes into the facility, generate clinical supplies, and support technology transfer to commercial GMP facilities as programs mature.

This position will report to the SVP of Genetic Therapies Research and participate as a member of a cutting-edge scientific team devoted to mastering the science of rAAV manufacturing and delivering the next generation of genetic therapeutics to patients in need. The Director will work collaboratively with process development to transfer and validate new gene therapy vector manufacturing processes. The Director will utilize their experience in scale-up and process operational optimization to ensure success. The Director will collaborate with QA, CMC program management, supply chain, regulatory affairs, commercial operations and facilities support personnel, as well as other key stakeholders within the growing Vertex organization.

Responsibilities:

  • Support management of external GMP vendors for clinical supplies for ongoing programs
  • Participate in Vertex's GMP facility design, specify equipment, and lead commissioning of the GMP clinical supply facility
  • Lead the drafting and maintenance of SOPs for operation of the facility
  • Hire and ensure proper training of a GMP operations team
  • Lead upstream, downstream, and fill/finish operations for clinical material supply
  • Provide performance feedback and mentor staff for continuous growth and development
  • Develop training curricula, identify equipment calibration requirements, and maintain facility schedule to ensure maintenance of a qualified operational facility
  • Schedule projects to optimize the capacity of the facility and meet project timelines
  • Determine process material supply requirements for operations, establish standard flow of materials in and optimal waste management out
  • Lead MSAT activities bringing in new processes and supporting technology transfer to commercial GMP manufacturing
  • Lead process operational optimization and continuous improvement
  • Plan and manage operating budget
  • Ensure delivery of clinical supplies in a timely, compliant manner, while staying within budget
  • Develop and implement GMP policies and procedures to ensure operations are compliant with all regulatory, environmental, and safety requirements
  • Ensure that documentation of all activity is accurate and compliant with quality requirements
  • Provide timely production status reports to interested parties

Requirements:

  • MS or BS in a biological science required, biochemical or chemical engineering degree preferred
  • A minimum of 10+ years' experience in bioprocess engineering
  • Demonstrated experience directing and supervising personnel in a biotherapeutic GMP facility
  • Extensive experience managing a biotherapeutic GMP clinical manufacturing operation, Gene Therapy operation experience strongly desired
  • Strong understanding of upstream, downstream and fill/finish operations and process scale-up
  • Demonstrated people leadership skills with experience mentoring staff for growth and development
  • Experience in budget management and continuous improvement
  • Strong understanding of CMC quality requirements for clinical processes
  • Demonstrated ability to support CMC regulatory affairs with generation of required process documentation
  • Experience managing inspections by various health agencies
  • Ability to communicate clearly and efficiently
  • Strong planning and scheduling skills
  • Strong collaborative team player and team leader
  • Effective, timely, and risk-based decision-making skills
  • Takes initiative and ownership of program success
  • Experience designing GMP facilities, specifying and commissioning equipment desired

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