Remote Director, CMC External Operations Biologics

Summary

Join our team as a strategic and technical leader to build upon our expertise in ADC pipeline development from early stage clinical studies to late stage clinical and product commercialization.

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 anti-body 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

Responsibilities

• Provide expert leadership in the process development of antibodies and ADCs, overseeing both strategic and executional activities at CDMO partners
• Provide operational and technical oversight for the Upstream cell culture and Downstream purification and formulation activities. Coordinate with the Analytical development teams to support ongoing GMP operations
• Lead and guide process characterization, validation studies, and technology transfer initiatives for antibody and protein-based therapeutics from early clinical phases through a successful global BLA filing and commercial manufacturing
• Work closely with the CDMO manufacturing facilities to ensure alignment in process development, scale-up, and manufacturing activities to meet project deliverables. Ownership of product campaign readiness, execution, and operational performance measures for CDMO partners
• Technical assessment and definition of site selection scale-up strategy for ADC manufacturing network
• Facilitate technology transfer and ensure consistency and scalability between sites, maintaining high-quality standards and regulatory compliance
• Coordination of complex investigations and process improvement opportunities, working closely with site MS&T organization on detailed data trend analysis and associated characterization work to be completed in support of process understanding and improvements
• Engage with Day One Bio ADC Product Team and associated R&D and Commercial functions to establish line of sight to program commercialization. Integrating CMC strategy for antibody/ADC development to achieve Target Product Profile (TPP)
• Communication with partners to align on manufacturing feasibility, critical quality attributes (CQAs), and specifications throughout development
• Ensure the integrity, organization, and integration of CMC process development and scale-up datasets in support of regulatory submissions

Benefits

This position has the potential to be fully remote. Occasional travel will be required for Corporate, CMC and CDMO meetings