[Hiring] Senior Director, Manufacturing Sciences & Technologies @ADC Therapeutics America Inc

Role Description

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.

Qualifications

• 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.