Senior Director, Manufacturing Sciences & Technologies at ADC Therapeutics America Inc

New Providence, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Aug, 26

Salary

0.0

Posted On

20 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

MSAT Strategy, CDMO Management, Bioconjugation, Process Validation, Technology Transfer, CMC Regulatory, cGMP Compliance, Root Cause Analysis, Lifecycle Management, Aseptic Operations, Process Characterization, Risk Mitigation, CPV Metrics, Strategic Leadership, Cross-functional Collaboration, Technical Due Diligence

Industry

Description

Description Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives. Why ADC Therapeutics? ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States, conditional approval from the European Commission and conditional approvals in other countries. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use. We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn. 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. Requirements 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. ADC Therapeutics is an equal opportunity employer and will consider qualified applicants for employment. We are committed to building collaborative, engaged teams and fostering a professional and respectful work environment where employees are empowered for success.

Responsibilities

Lead the MSAT function to provide technical oversight and end-to-end process ownership for ADC drug substances and products manufactured via external CDMOs. Ensure robust, scalable, and compliant manufacturing processes while supporting regulatory submissions and lifecycle management.