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