Description

Director, Process Sciences, CMC

Headquarters Location: South San Francisco, CA, Company relocating to Emeryville, CA Fall of 2026
Candidate Location: Hybrid
Travel Required: 5% to 15%
Reports To: Vice President, Protein Sciences & Early CMC
Department: Protein Sciences & Early CMC
Position Type: Full-time, Exempt

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.

Job 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.

Minimum Qualifications:
• 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.
• Presentation of a scientific seminar is required during the interview process.

Preferred Qualifications:
• 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

How You Will Work:
• Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
• Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
• Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
• Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
• Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
• Contributes to strategy and innovation. Contributes to or leads elevating and actionable strategies. Ideates and creates unique opportunities to advance the organization.
• Demonstrates leadership and a commitment to organizational values. Takes ownership and has a strong sense of personal accountability. Consistently achieves or exceeds goals and expectations. Puts significant emphasis on living / upholding company values.
• Demonstrates ability and commitment to building effective teams. Attracts, develops, and retains diverse top talent. Aligns, mobilizes, and engages others to achieve and sustain peak performance.
• Has a track record of driving vision and purpose in teams.

Compensation, Benefits, and So Much More
• The expected salary range for this role based on the primary location for this position in California is $220,000.00 - $235,000.00 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
• 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.

Conditions of Employment
• Background investigations are required for all positions at CytomX, consistent with applicable law.