Senior Director, Manufacturing Sciences & Technologies

ADC Therapeutics•New Providence, NJ

2d•Remote

About The Position

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.

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.

Nice To Haves

Domestic and international travel approximately 10-20%, primarily to CDMOs.

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, 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.