Director, CMC External Operations - Biologics

October 3

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Day One Biopharmaceuticals

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Oncology • Cancer • Drug Development • Biotechnology • Pediatric Oncology

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Description

• Day One Biopharmaceuticals is seeking a Director to lead external operations for biologics. • The Director will oversee CDMO network development of monoclonal antibody processes. • Responsibilities include scale-up and GMP manufacturing for clinical supply. • Lead process characterization, validation studies, and technology transfer initiatives. • Engage with partners to align on manufacturing feasibility and quality attributes. • Compile and review CMC sections for regulatory submissions such as IND and BLA. • Occasional travel required for meetings with Corporate, CMC, and CDMO partners.

Requirements

• Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with at least 10+ years of manufacturing and MS&T experience in an industrial setting. • B.S or M.S. in a relevant field with at least 15+ years of manufacturing and MS&T experience in an industrial setting. • Direct site-focused monoclonal antibody manufacturing experience and MS&T Upstream & Downstream experience strongly preferred. • Extensive expertise in CMC strategy and antibody or ADC drug development. • Expertise in developing, optimizing, troubleshooting, and tech transferring processes for antibodies or ADCs. • Significant experience interfacing with and providing effective oversight of GMP operations at CDMOs. • Deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes. • Proficient in analyzing and interpreting complex datasets from multiple methodologies. • Demonstrated effectiveness in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills. • Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses. • Comprehensive knowledge of ICH and FDA regulations and guidance for biologics and ADCs. • Flexible and “hands-on” to navigate between strategic and technical roles. • Able to work in a fast-paced bio-tech environment while managing multiple projects. • Ability to create collaborative and trusting relationships internally and with external partners. • Excellent verbal and technical writing communication skills with the ability to communicate with vendors, internal teams (including management), and regulators. • Language Skills: Mandarin Chinese is desired but not a requirement to collaborate with China CDMO partners.