Director, Biologics Process Development

Position Summary

Reporting the Senior Vice President, Chemistry Manufacturing and Controls (CMC), the Director, Biologics Process Development will provide strategic and technical leadership for outsourced biologics drug substance development and manufacturing activities across clinical and commercial stages. This role will serve as the company's upstream/downstream process development and manufacturing subject matter expert, leading external CDMO/CMO partnerships to ensure reliable clinical supply while advancing manufacturing processes toward commercial readiness. The Director will be responsible for process development oversight, manufacturing execution, process characterization, technology transfer, process validation (PPQ), regulatory support, and lifecycle management activities required to enable successful late-stage development and commercial manufacturing. Working cross-functionally with CMC, Quality, Regulatory, Program Management, and external partners, this individual will drive technical decision-making, manage development and manufacturing risks, and ensure alignment of process development strategies with broader corporate objectives and product commercialization plans.

Essential Job Functions and Responsibilities

• Lead upstream/downstream process development activities for biologics drug substance programs from early development through commercialization
• Provide strategic and technical leadership for process development, manufacturing, and CMC execution across multiple development programs
• Serve as the technical lead and subject matter expert for external CDMO partnerships, including selection, governance, performance management, and manufacturing oversight
• Oversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities to support late-stage development and product launch
• Provide technical oversight of manufacturing operations, reviewing process performance, manufacturing readiness, deviations, investigations, change controls, and ongoing process improvements
• Lead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies to ensure reliable clinical and commercial supply
• Drive development and execution of technology transfer strategies, comparability assessments, process control strategies, and manufacturing documentation.
• Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory, Supply Chain, and Program Management to achieve CMC objectives and manufacturing milestones
• Support regulatory submissions and health authority interactions, including preparation and review of IND, IMPD, BLA, and MAA CMC content and responses.
• Ensure compliance with cGMP requirements, global regulatory expectations, and internal quality standards while maintaining inspection and commercial readiness
• Provide clear technical recommendations, risk assessments, and strategic guidance to senior leadership to support program and portfolio decisions

Preferred Qualifications

• Ph.D. or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, or a related scientific discipline with 8+ years of progressive CMC experience in the life sciences industry or an equivalent combination of academic and industry experience
• Proven experience leading biologics process development, prefer experience in mammalian cell culture
• Provide technical oversight of outsourced manufacturing through CDMO partnerships
• Deep expertise in monoclonal antibodies, recombinant proteins, or other biologic modalities, with strong knowledge of upstream and downstream manufacturing processes
• Experience with Antibody-Drug conjugation and downstream purification is a plus
• Demonstrated experience with technology transfer, scale-up, process characterization, process validation (PPQ), and commercial manufacturing readiness
• Strong understanding of downstream purification technologies, including chromatography, filtration, viral clearance, and UF/DF operations
• Experience leading manufacturing investigations, technical troubleshooting, risk assessments, change management, and continuous improvement initiatives in cGMP environments
• Working knowledge of global regulatory requirements, including FDA, EMA, ICH, and biologics CMC development and commercialization standards
• Experience supporting regulatory submissions, health authority interactions, and preparation of CMC content for INDs, BLAs, MAAs, and related filings
• Proven track record supporting late-stage development, successful PPQ campaigns, inspection readiness, and commercialization activities
• Experience managing manufacturing networks across multiple global CDMOs and commercial-scale manufacturing operations
• Familiarity with modern biomanufacturing technologies, including single-use systems, digital manufacturing platforms, electronic batch records, and manufacturing data analytics tools
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

This position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel