Director, Process Sciences, CMC
About The Position
About CytomX Therapeutics: CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel PROBODY® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. Learn more at www.cytomX.com. Who You Are and What You’ll Do: You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will be responsible for leading late-stage process development and commercialization efforts at CDMOs to support CytomX’s clinical-stage ADC program, CX-2051. Additionally, you will lead CMC BLA readiness by authoring dossiers and preparing health authority responses, while developing analytical control strategies for product life cycle management.
Requirements
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or Pharmaceutical Sciences with 12+ years of hands-on industry experience; M.S. in Biochemistry, Chemical engineering, or Pharmaceutical Sciences with 15+ years on hands-on industry experience in transitioning the programs from Phase I through Phase III and commercialization.
- Hands-on expertise in end-to-end ADC process development, including MAb production, conjugation chemistry, and downstream purification. Mastery of Quality by Design (QbD) principles, process characterization, and process validation is essential for commercial readiness.
- Hands-on involvement in transitioning programs through Phase 3, Process Performance Qualification (PPQ), BLA (Biologics License Application) or NDA filings, and global product launches.
- Deep knowledge of analytical method development, qualification, and validation. You must be able to drive specifications for MAb intermediates, drug substance (DS), and drug product (DP), as well as manage complex impurity profiling and structural elucidation.
- Extensive experience authoring and reviewing CMC dossiers (IND/CTA and BLA/MAA) and preparing responses to health authority questions. You must have a thorough understanding of ICH guidelines for drug registration and lifecycle management.
- Proven ability to lead multidisciplinary teams across Regulatory Affairs, Quality Assurance (QA), Manufacturing, and Supply Chain.
Nice To Haves
- Experience in successfully selecting and managing Contract Development and Manufacturing Organizations (CDMOs). This includes overseeing technology transfer, scale-up operations, lot release, and stability programs in a predominantly outsourced manufacturing model.
- Mentor scientists to promote a culture of scientific excellence, and build high-performance CMC teams
Responsibilities
- Direct late-stage process characterization and optimization for monoclonal antibodies, cytotoxic payloads, linkers, and the final conjugated ADC.
- Define regulatory-ready analytical control strategies, ensuring comprehensive characterization, method validation, and stability indicating profiles.
- Manage analytical comparability assessments and process improvements to ensure supply reliability, process robustness, and cost-of-goods (COGS) reductions.
- Drive BLA readiness by authoring, reviewing, and endorsing CMC dossiers (e.g., IND/CTA and BLA/MAA) in alignment with global regulatory expectations (ICH guidelines).
- Prepare CMC teams to respond to regulatory inquiries (information requests).
- Partner with Analytical (AFD) and Quality Assurance (QA) to enforce and maintain strict adherence to cGMP manufacturing and quality standards.
Benefits
- A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
- A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
- A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
