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Solid Biosciences

Director, External Process Development

306 - Process Development – Cambridge, Massachusetts
Department 306 - Process Development
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Summary:

Solid Biosciences is looking to hire a Director, External Process Development. In this exciting new role the Director, External Process Development will provide technical, operational, and strategic leadership, and expertise in monoclonal antibody (mAb) cell line generation, upstream process development, downstream process development, analytical development, and technology transfer.

Key Duties & Accountabilities:

  • Ensure Contract Development and Manufacturing Organizations (CDMOs) generate a suitable production cell line, develop a scalable process, and produce high quality product for clinical trials by providing oversight through cell line generation, upstream process development, downstream process development, analytical development, and technology transfer
  • Actively manage CDMOs network to develop a mAb process to supply material for the Phase I clinical trial
  • Oversee technology transfer between process development labs, and from process development to manufacturing
  • Act as the primary contact with the CDMOs to ensure effective collaborations with relevant internal departments (Process Development, Manufacturing, Quality, Regulatory Affairs, Clinical Operations, and Program Management), and the corresponding departments within the CDMOs
  • Ensure phase-appropriate process development, with an appreciation of late-stage manufacturing, including process characterization and process validation activities
  • Performs other related duties include ad hoc projects as required by position

Competencies Required:

  • Excellent communication, technical, and organizational skills are required
  • Must be a team player prepared to work in, and embrace a team-based culture
  • Proven leadership skills

Knowledge: Education, Experience, & Skills:

  • PhD with 10+ years of relevant experience working in mAb process development and/or analytical development in the Pharmaceutical/biotech industry
  • In-depth technical and regulatory understanding of mAb drug development to support Phase I clinical trial, as well as late-stage development through commercialization
  • Proven leadership experience and people management skills with the desire and ability to work in a fast-paced, start-up environment
  • Strong collaboration and team-building, communication, and organizational skills required
  • Experience working with and managing third party contractors and vendors
  • Excellent written and verbal communication skills

Travel Commitment:

  • Some travel may be required
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  • Location
    Cambridge, Massachusetts
  • Department
    306 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor
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