MSAT Strategy and Leadership - 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. Manufacturing Process Oversight (External Manufacturing) - Ensure MSAT team membership within ADCT’s Production Management Teams to serve as manufacturing process interface with CDM - Os for all MSAT related activities. - Oversee and guide: Process development, scale up, and tech transfer at/to CDM - Os, 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. Process Lifecycle Management - 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. Regulatory & Quality Support - Serve as the senior-level accountable MSAT person for regulatory submissions and inspections, including IN - Ds, BL - As, MA - As, supplements to these filings. - Author, review, and approve CMC regulatory sections and responses. - Support health authority inspections and technical audits of CDM - Os. - Partner closely with Quality to ensure compliance with cGMP, ICH, and global regulatory expectations. - Ensure sound scientific justifications for process control strategies, specifications, and lifecycle changes. Cross Functional Collaboration - 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. Risk Management & Continuous Improvement - Establish and track critical process parameters (CP - Ps) 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 CDM - Os and Production Management Teams. Requirements Who You Are: - Advanced degree (MS or PhD) 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 CDM - Os. ADC Therapeutics is an equal opportunity employer and will consider qualified applicants for employment. We are committed to building collaborative, engaged teams and fostering a professional and respectful work environment where employees are empowered for success.