Senior Director, Manufacturing Sciences & Technologies

Job Summary

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.

What You'll Do

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)

• Accountable for overall manufacturing process stewardship, ensure robust process knowledge management and align process understanding within ADCT and at the CDMO partners.
• Partner with Quality and Supply Chain to ensure ADCT's Production Management Teams effectively interface and manage CDMO performance.
• Oversee and guide: MSAT activities at CDMOs, process characterization, validation (PPQ), 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.