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.
Requirements
Who You Are :- Advanced degree (MS or PhD) in Biochemistry, Chemical Engineering, Biotechnology, or related field; BS with significant industry experience considered.
- 12+ years of relevant experience including biologics manufacturing, CMC operations, and CDMO management.
- Extensive experience in commercial GMP manufacturing operations, process validation, CPV, and regulatory submission preparation.
- 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 relevant bioconjugate technologies is preferred (antibody, high potency linker-payload, conjugation, aseptic fill and lyophilization).
- 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 critical thinking skills.
- Ability to mentor, influence, and drive change across a remote organization.
- Domestic and international travel up to 20%, primarily to CDMOs.
