Associate Director, Cell Culture Process Development

CytomX Therapeutics   •  

South San Francisco, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 61 days ago

This job is no longer available.

The Opportunity:

Professional Responsibilities:

  • The lead role in Cell Culture team developing and transferring projects to GMP manufacturing to support the clinical pipeline.
  • Manage cell culture resources and to support early and late stage projects.
  • Grow and enhance the cell culture group's capabilities to meet commercialization objectives of the company.
  • Develops strategies to enhance the cell line development and cell culture manufacturing platform.
  • Strengthen internal scientific expertise by providing technical leadership and building appropriate technical capabilities.
  • Working closely with colleagues in Process Sciences to ensure coordination of project activities across all programs.
  • Key contributor to CMC sections in IND/CTA submissions and BLA/MAA submissions, evaluating comparability strategies and CQA assessments.
  • Stay current with emerging trends in and introduce new technology to enhance workflow and capabilities.
  • Participate in establishment of specifications for drug substance and drug product for clinical candidates.
  • Supervise technical transfer activities to CMOs. Review and approve GMP supportive documentation.
  • Mentor and develop team members and emphasize best practices.
  • Partner with QA and Regulatory to support batch release, regulatory submissions and program specific communications with US and European regulatory agencies.
  • Partner with Protein Sciences to establish process and criteria for manufacturability assessments and for material generation.

Education/Experience:

  • PhD. in biochemistry, chemical engineering or related field with 8-10 years, or masters degree with 10-15 years, of relevant industrial experience

Professional Requirements:

  • Demonstrated experience in managing staff and projects.
  • Broad experience in cell line and cell culture process development of monoclonal antibody therapeutic candidates is required.
  • In-depth knowledge and hands-on experience in cell line development and lab scale cell culture including high throughput technologies such as ambr.
  • Proficiency with statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
  • Experience with transfer of process to GMP manufacturing is required.
  • Experience with writing and reviewing development reports, SOPs, manufacturing batch record and deviations is required.
  • Prior experience contributing to preparation of documents for regulatory submissions for IND/CTA applications and BLA/MAA submissions for product registration is required.
  • Experience coordinating projects and resources in support of new and ongoing projects at all stages of development is necessary.
  • Ability to mentor and motivate teams to achieve high performance and practices that are on par with best industry standards.
  • Ability to set goals and prioritize tasks and resources to achieve superior work quality and efficiency.

Personal Characteristics:

  • Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun
  • A strong work ethic, excellent oral and written communication skills with ability to communicate effectively.