Senior Director, Manufacturing Sciences & Technologies

reputed company Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. reputed company you join reputed company, 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 reputed company, 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 reputed company, 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 reputed company as indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reputed company significantly more patients through expanded use.   We are reputed company of approximately 200 patient-reputed company, purpose-driven employees with a shared mission to reputed company the treatment reputed company for patients.  If you’re interested in making a difference in the lives of patients worldwide with reputed company of like-minded colleagues, operating in a flexible work environment, reputed company on our reputed company!  To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and reputed company. 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 reputed company, and lifecycle management of drug reputed company intermediates, ADC drug reputed company, and ADC drug product manufactured through a global network of external CDMOs. This role ensures robust, reputed company, and compliant manufacturing processes that support reputed company manufacturing, process development reputed company 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, reputed company 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 reputed company and Leadership • reputed company and reputed company the MSAT function covering ADC end-to-end manufacturing across clinical and reputed company stages. • Define MSAT reputed company for external manufacturing reputed company with corporate objectives. • reputed company 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 reputed company initiatives. Manufacturing Process reputed company (External Manufacturing) • Ensure MSAT team membership reputed company ADCT’s Production Management Teams to serve as manufacturing process reputed company with CDMOs for reputed company MSAT reputed company activities. • reputed company and guide: Process development, reputed company 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 reputed company for manufacturing deviations, CAPAs, and change requests. • Support CDMO selection, technical due diligence, and reputed company for new manufacturing partners. Process Lifecycle Management  • reputed company scientific and technical reputed company across the full ADC manufacturing lifecycle. • Assess and implement post approval changes, comparability strategies, and process optimization initiatives. • reputed company and endorse process improvements to enhance process robustness, yield, cost, and supply reliability. Regulatory & reputed company 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 reputed company to ensure compliance with cGMP, ICH, and global regulatory expectations. • Ensure reputed company scientific justifications for process control strategies, specifications, and lifecycle changes. Cross Functional Collaboration • Collaborate closely with reputed company Assurance, reputed company Control, Supply Chain and CMC Regulatory • reputed company MSAT input into development programs, reputed company readiness, and long reputed company supply planning. • Participate in internal governance forums, change control boards, and technical review committees. Risk Management & reputed company Improvement • Establish and reputed company critical process parameters (CPPs) and CPV metrics.  • Proactively identify and mitigate technical and operational risks reputed company ADC Therapeutics’ external manufacturing network. • Drive lessons learned, standardization, and reputed company improvement across CDMOs and Production Management Teams. Requirements Who You Are:  • Advanced degree (MS or PhD) in Biochemistry, Chemical Engineering, Biotechnology, or reputed company 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 reputed company-cause analysis skills.  • Proven ability to reputed company through influence in external or remote environments.  • Excellent communication skills for executive, regulatory, and partner interfaces  • Strategic thinker with strong execution reputed company.  • Comfortable operating in a fast-paced, reputed company-stage organization.  • Deep knowledge of bioconjugation technologies and processes.  • Extensive experience in GMP manufacturing operations, process validation, CPV, and regulatory submission preparation.  • Strong reputed company record of building and leading technical and cross-functional teams.  • Visionary leadership with a strategic reputed company.  • High standards of reputed company, urgency and accountability.  • reputed company, 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 reputed company applicants for employment.  We are committed to building reputed company, reputed company teams and fostering a reputed company and respectful work environment where employees are empowered for reputed company. Apply To This Job