Job Details

We are partnered with an innovative and growing immune-oncology biotech based out of South San Francisco that is seeking a talented and proven Director of Analytical Development and Quality Control to lead efforts on their mAb products, overseeing outsourced testing across the entire portfolio. This is a great opportunity for an analytical leader who will have impact on programs from preclinical through late stage.

Responsibilities:

• Oversee relationships with CDMOs/CTLs/CROs, ensuring GMP compliance and quality standards
• Guide development and validation of analytical testing strategies, ensuring reliability and regulatory alignment
• Lead outsourced quality control functions, ensuring appropriate testing methods and regulatory compliance for monoclonal antibodies
• Ensure compliance with GMP standards and regulatory guidelines across outsourced manufacturing, testing, and analytical activities
• Collaborate with internal teams to align product development, manage risks, and ensure timely regulatory submissions and documentation

Qualifications:

• A PhD or MSc in Biochemistry, Chemistry, or a related discipline in life science with a minimum of 10 years of industry experience in leading analytical development and QC, with at least 5 years in a leadership role managing outsourcing analytical activities
• Strong understanding and expertise in monoclonal antibodies, including analytical testing using HPLC, ELISA, SDS-PAGE, and other bioanalytical techniques
• Demonstrated experience in managing outsourced testing relationships
• Strong preference for experience across clinical through commercial stage with expertise in authoring relevant sections in INDs, BLAs, or similar regulatory filings

Contact:

For a confidential discussion, reach out to Amit at ...@meetlifesciences.com.