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  • ID
    #5794530
  • Job type
    Permanent
  • Salary
    TBD
  • Source
    Vertex Pharmaceuticals Inc (US)
  • Date
    2020-11-12
  • Deadline
    2021-01-11

Vacancy expired!

The leader of the Manufacturing Technical Operations Cell Sciences Team will be responsible for enabling the commercial manufacture of cell culture products to support our cellular therapies. They will oversee the implementation of commercially capable processes for manufacturing ensuring the sustainability and efficiency of process. This leader will have an excellent understanding of cell culture engineering, cell biology, biologics scale-up, and cGMP manufacturing with mammalian systems. As a leader of this critical effort, they will be able to foster a strong attitude of collaboration and work closely with all other groups within the organization. This role will report to the VP of Vertex Cell and Genetic Therapies unit of Vertex Pharmaceuticals within the Commercial Manufacturing and Supply Chain.

Key Responsibilities:
  • Work with colleagues across Vertex, including Process Development and Vertex Cell and Gene Therapy, to bridge cell culture technology from development into commercialization and commercial manufacturing
  • Serve as Subject Matter Expert on manufacturing of cell culture and cell-based products, supporting development, manufacturing, investigations, process improvements and support regulatory filings, technical documents, inspections, process validations
  • Work with contract development and manufacturing organizations (CDMOs), on tech transfer, process installation, process qualification, and ongoing manufacturing oversight of cell culture-based products
  • Build and lead a team of scientists and engineers to support cell-based products to guide global initiatives and cross-functional projects
  • Translating business requirements into process changes in support of product and manufacturing strategies.
  • Leading technology transfer to and from external manufacturing organizations.
  • Oversee ongoing technical support for manufacturing processes being manufactured internally or at contract manufacturing sites.
  • Authoring technical reports, manufacturing instructions, process validation documents and regulatory submissions.
  • Deliver innovative and consistent best practices for process design and manufacturing to ensure clear communication and alignment.

Minimal Requirements:
  • Ph.D. in cell culture engineering, cell biology, or equivalent field
  • At least 10 years of experience in implementing cell culture systems for cGMP manufacturing
  • Demonstrated experience in scaling cell culture processes beyond the bench-scale into large production scale (multi-1000L)
  • Experience with commercial cell culture systems, including single-use bioreactors, commercial media formulations, and high cell-density cell handling systems.
  • Experience in tech transfer and scale up of cell culture systems from pilot to production scale, including transfer to various Contract Development and Manufacturing Organizations (CDMOs)
  • Experience establishing and maintaining robust PPQ and process control strategies.
  • Several years leading and managing a team of dedicated scientists and technicians
  • Strong cross functional leadership skills including refined verbal and written communication skills
  • Strong engineering skills, including facility fit and process engineering assessment into different facilities.

Preferred skills:
  • Experience with primary and stem-cell derived therapies
  • Experience with cellular analytics, including flow cytometry.
  • Experience with allogeneic or autologous cell therapy
  • Experience with complex regulatory filings, including initial BLA and post-approval regulatory activities.

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Vacancy expired!

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