Senior Director, Manufacturing Sciences – Technologies

• Job Responsibilities
• Lead and develop the MSAT function covering ADC end-to-end manufacturing across clinical and commercial stages.
• Define MSAT strategy for external manufacturing aligned with corporate objectives.
• Develop and mentor a high‑performing MSAT team with deep expertise in biologics, highly potent payloads, and aseptic operations.
• Serve as a key member of the Operations Management Team to contribute to long‑term supply, risk mitigation, and operational excellence initiatives.
• Ensure MSAT team membership within ADCT’s Production Management Teams to serve as manufacturing process interface with CDMOs for all MSAT related activities.
• Oversee and guide process development, scale up, and tech transfer at/to CDMOs; process characterization and validation (PPQ); ongoing process monitoring and CPV programs.
• Ensure consistent process understanding and control across global manufacturing partners.
• Drive effective issue resolution for manufacturing deviations, CAPAs, and change requests.
• Support CDMO selection, technical due diligence, and onboarding for new manufacturing partners.
• Provide scientific and technical oversight across the full ADC manufacturing lifecycle.
• Assess and implement post‑approval changes, comparability strategies, and process optimization initiatives.
• Oversee and endorse process improvements to enhance process robustness, yield, cost, and supply reliability.
• Serve as the senior‑level accountable MSAT person for regulatory submissions and inspections, including INDs, BLAs, MAAs, and supplements to these filings.
• Author, review, and approve CMC regulatory sections and responses.
• Support health authority inspections and technical audits of CDMOs.
• Partner closely with Quality to ensure compliance with c GMP, ICH, and global regulatory expectations.
• Ensure sound scientific justifications for process control strategies, specifications, and lifecycle changes.
• Collaborate closely with Quality Assurance, Quality Control, Supply Chain, and CMC Regulatory.
• Provide MSAT input into development programs, commercial readiness, and long‑range supply planning.
• Participate in internal governance forums, change control boards, and technical review committees.
• Establish and track critical process parameters (CPPs) and CPV metrics.
• Proactively identify and mitigate technical and operational risks within ADC Therapeutics’ external manufacturing network.
• Drive lessons learned, standardization, and continuous improvement across CDMOs and Production Management Teams.

Requirements

• Advanced degree (MS or Ph D) in Biochemistry, Chemical Engineering, Biotechnology, or related field; BS with significant industry experience considered.
• 10+ years of relevant experience including biologics manufacturing, bioconjugation, CMC operations, and CDMO management.
• Strong scientific problem‑solving and root‑cause analysis skills.
• Proven ability to lead through influence in external or remote environments.
• Excellent communication skills for executive, regulatory, and partner interfaces.
• Strategic thinker with strong execution focus.
• Comfortable operating in a fast‑paced, commercial‑stage organization.
• Deep knowledge of bioconjugation technologies and processes.
• Extensive experience in GMP manufacturing operations, process validation, CPV, and regulatory submission preparation.
• Strong track record of building and leading technical and cross‑functional teams.
• Visionary leadership with a strategic mindset.
• High standards of excellence, urgency and accountability.
• Collaborative, team‑oriented approach.
• Strong organizational and problem‑solving skills.
• Ability to mentor, influence, and drive change across a remote organization.
• Domestic and international travel approximately 10‑20%, primarily to CDMOs.
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