We are a dynamic biopharmaceutical organization focused on transforming cancer treatment through innovative therapies, including multispecific antibodies and antibody-drug conjugates (ADCs). Our mission is to advance biologics that target solid tumors and enhance immune system response, creating impactful solutions for patients worldwide.
Role Summary:
The Director of Process Development - Antibodies will lead efforts to bridge operations between our U.S. base in Redmond, WA, and our manufacturing and R&D facility in Chengdu, China. This position will drive the development and optimization of processes for antibody and ADC therapeutics while ensuring alignment with global standards. The Director will collaborate across teams and geographies, overseeing technology transfer, process characterization, and regulatory submissions. Proficiency in Mandarin Chinese (reading and writing) is required to facilitate communication and coordination with the Chengdu team and global partners.
Key Responsibilities:
Direct strategic and operational activities for process development of antibodies and ADCs in Redmond, WA.
Oversee multidisciplinary teams across Downstream, Upstream, Formulation, and Analytical Development functions.
Lead process characterization, validation, and technology transfer initiatives for biologic and protein therapeutics.
Partner with Chengdu's manufacturing and R&D teams to ensure alignment in process design, scale-up, and manufacturing.
Maintain consistency in quality standards and regulatory compliance across sites.
Manage technology transfer and process coordination to support GMP manufacturing.
Build strong collaborations with international partners for the co-development of antibodies and ADCs.
Align process development strategies to meet shared goals, including manufacturing feasibility and critical quality attributes (CQAs).
Develop and implement phase-appropriate analytical methods to support development and manufacturing.
Collaborate with teams to define CQAs and establish effective characterization and release strategies.
Supervise analytical data management and reporting to support regulatory submissions.
Provide technical guidance during production campaigns, working with QC and manufacturing teams in both Redmond and Chengdu.
Troubleshoot technical challenges to ensure high-quality outcomes.
Lead the preparation and submission of CMC documentation for regulatory filings (e.g., IND, BLA).
Participate in project teams to align regulatory requirements with process development initiatives.
Qualifications and Skills:
Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with a minimum of 10+ years of relevant industry experience.
M.S. in a similar field with at least 12+ years of relevant experience.
Extensive experience in CMC strategy and antibody or ADC development.
Proven expertise in developing, optimizing, and transferring manufacturing processes and analytical methods.
Strong track record of managing cross-functional collaborations and global partnerships.
In-depth knowledge of GMP, ICH, and FDA guidelines for biologics and ADCs.
Experience in preparing regulatory filings and addressing agency queries.
Fluency in reading and writing Mandarin Chinese is essential to facilitate collaboration with global teams.