Director, Process Development/CMC – Antibody Biologics
2 weeks ago
SystImmune is seeking a highly experienced Director of Process Development - Antibodies to lead the development of novel therapeutic multi-specific antibodies and antibody-drug conjugates (ADCs). As a key member of our team, you will be responsible for bridging our operations between the U.S. and China, collaborating with our manufacturing facility and R&D center in Chengdu, China, and engaging with global partners in antibody and ADC co-development.
Key Responsibilities- Technical Leadership: Provide expert leadership in the process development of antibodies and ADCs, overseeing both strategic and day-to-day activities in Redmond WA.
- Collaboration with Chengdu Facility: Work closely with the manufacturing facility and R&D center in Chengdu to ensure alignment in process development, scale-up, and manufacturing activities.
- Global Partner Interaction: Engage with global partners in antibody and ADC co-development to support joint ventures, ensuring successful integration of process development strategies.
- Analytical Strategy Development: Develop and implement analytical strategies to support antibody and ADC development, including phase-appropriate analytical development, characterization, and release strategies.
- Manufacturing and QC Partnership: Partner with manufacturing and QC teams in both Redmond and Chengdu to ensure successful product release, characterization, and scaling.
- Regulatory Submissions: Compile and review CMC sections for IND, BLA, and other regulatory submissions.
- Education: Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with at least 10+ years of laboratory experience in an industrial setting.
- Experience: Extensive experience in CMC strategy and antibody or ADC drug development, with a deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes.
- Skills: Proficient in analyzing and interpreting complex datasets from multiple methodologies, with expertise in method robustness assessment, validation, and testing.
- Language Skills: Proficiency in reading and writing Mandarin Chinese is required to effectively collaborate with the Chengdu facility and global partners.
SystImmune offers a comprehensive benefits package, including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays.
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