Associate Director, Drug Substance Operations – Wilmington Biotech

Job Description

Welcome to the Future of Precision Oncology — Join Us in Wilmington, DE! We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science.

ADC’s represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer‑killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers. The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035.

Innovations in linker technology, payload design, and AI‑driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities.

Our Wilmington facility is designed to meet the growing demand for high‑potency manufacturing, ensure supply‑chain resilience, and support the next wave of ADC launches. Importantly, this site will support both drug substance conjugation and drug product. This is more than a job – it’s a chance to be part of the next wave of cancer care. Whether you’re an engineer, scientist, operator, or quality expert, your work here will contribute to life‑changing therapies for patients around the world.

We invite you to become a part of our journey as the Manufacturing Associate Director, Drug Substance. This role offers you the chance to contribute to the site’s development and ensure successful GMP manufacturing. In this position the Manufacturing Associate Director will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T the Manufacturing Associate Director will provide comprehensive manufacturing and technical leadership to the DS organization.

This position will continue within the role from design through operation of the facility.

• Lead and engage with the engineering design firm in detailed design on all aspects of drug substance manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug substance area.
• Support equipment qualification deliverables including equipment commissioning & qualification, IOQ, etc.
• Creation and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
• Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing.
• Support technical deliverables within Drug Substance to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Explain complex technical issues to external customers / agencies.

• Bachelor’s degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience.
• Start‑up experience in a large‑scale commercial drug product facility highly desirable.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
• Experience with chromatography and TFF operations will be advantageous.
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and…