We are a forward-thinking biopharmaceutical organization committed to developing transformative cancer therapies. Specializing in small molecule therapeutics, we aim to advance innovative treatments that address the complexities of solid tumors and enhance immune system responses.
Role Summary:
The Director of Process Development/CMC - Small Molecules will play a key leadership role in bridging U.S. and international operations, driving collaboration between the Redmond, WA headquarters and a manufacturing and R&D facility in Chengdu, China. This position will oversee the development and optimization of small molecule processes, ensuring alignment with global standards and regulatory requirements. The role demands expertise in process development, technology transfer, and regulatory submissions, as well as fluency in Mandarin Chinese (reading and writing) to facilitate communication with global teams.
Key Responsibilities:
Provide strategic and operational oversight for small molecule process development initiatives.
Lead process characterization, validation, and technology transfer efforts to support global therapeutic development.
Ensure seamless collaboration between Redmond and Chengdu teams to align objectives and maintain quality standards.
Work closely with the Chengdu manufacturing and R&D teams to ensure harmonized process development, scale-up, and manufacturing activities.
Facilitate technology transfer and establish consistency across sites, adhering to regulatory compliance.
Oversee material requests and delivery processes to ensure timely and compliant supply chain operations.
Collaborate with international partners to support joint development of small molecule therapeutics.
Align process development strategies with partner requirements, including manufacturing feasibility and critical quality attributes (CQAs).
Design and implement analytical methods and strategies for small molecule development.
Define CQAs and oversee analytical development, release, and stability testing with external partners.
Ensure the integrity and organization of CMC analytical datasets to support regulatory filings.
Partner with manufacturing and QC teams in Redmond and Chengdu to ensure successful product scale-up and release.
Troubleshoot technical challenges during production campaigns, maintaining operational excellence.
Lead the preparation and review of CMC documentation for regulatory submissions (e.g., IND, BLA).
Support cross-functional teams to ensure alignment with regulatory standards and submission requirements.
Qualifications and Skills:
Ph.D. in chemistry, pharmaceutical sciences, or related fields with a minimum of 10+ years of relevant industry experience.
M.S. in a similar discipline with at least 12+ years of relevant experience.
Extensive expertise in CMC strategy and small molecule drug development.
In-depth understanding of process design, optimization, and tech transfer for small molecule manufacturing.
Strong track record in developing and transferring analytical methods and troubleshooting challenges.
Proven experience interfacing with GMP contract test laboratories and contract manufacturing organizations.
Familiarity with EHS requirements for small molecule manufacturing processes.
Demonstrated success in managing regulatory inspections and preparing detailed filings.
Comprehensive knowledge of ICH and FDA regulations for small molecule therapeutics.
Fluency in reading and writing Mandarin Chinese is essential for effective communication and collaboration with global teams.