Senior Director, Manufacturing Sciences & Technologies

What You’ll Do

The Senior Director of Manufacturing Sciences & Technologies (MSAT) is a senior technical leader responsible for end-to-end process ownership, technical oversight, and lifecycle management of drug substance intermediates, ADC drug substance, and ADC drug product manufactured through a global network of external CDMOs. This role ensures robust, scalable, and compliant manufacturing processes that support commercial manufacturing, process development projects and clinical development, while serving as the senior-level technical support for internal Production Management Teams and external manufacturing partners. The position plays a critical role in process validation, technology transfer, continued process verification (CPV), change management, technical and regulatory support across antibody, linker-payload, conjugation, formulation, fill-finish, and packaging operations. This position reports to the Vice President, Global Supply & Operations. The role is remote based, with a preference for candidates located on the U.S. East Coast.

Job Responsibilities

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 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.

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 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.

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 (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.

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 CDMOs.