ADC Therapeutics
201 - 500 employees
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs).
Senior Director, Manufacturing Sciences – Technologies
🕒 May 22
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ADC Therapeutics
201 - 500 employees
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs).
📋 Description
• 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, 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 cGMP, 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 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 CDMOs.
🏖️ Benefits
• Flexible work environment
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