Associate Director, Drug Product Operations - Wilmington Biotech

Manufacturing Associate Director Drug Product

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, Delawarea bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. ADCs 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 jobit'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. Together, we'll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatmentone molecule at a time. We invite you to become a part of our journey as the Manufacturing Associate Director Drug Product. 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 drug substance organization.

Bring energy, knowledge, innovation to carry out the following :

• Lead and engage with the engineering design firm in detailed design on all aspects of the drug product 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).
• Execute automation sprints as necessary in the drug product area.
• Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ, etc.
• Perform process and facility fit activities to enable engineering and qualification runs of new products.
• Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated).
• Support technical deliverables within Drug Product to support the successful technology transfer.
• Lead Change controls and Quality Docs as appropriate required for new product introduction.
• Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Bringing appropriate stakeholders when required.
• Conduct all work activities with a strict adherence to the safety and compliance culture on site.
• Support the Authoring of electronic batch records, sampling plans, and standard operating procedures.

What skills you will need :

Required Skills : Adaptability, Antibody Drug Conjugates (ADC), Aseptic Processing, Communication, Cross-Cultural Awareness, Customer-Focused, Driving Continuous Improvement, Engineering Design, Freeze Drying, GMP Compliance, Leadership, Lean Six Sigma Process Improvement, Management Process, Manufacturing Quality Control, New Product Introduction Process, Organizational Compliance, Pharmaceutical Manufacturing, Pharmaceutical Microbiology, Process Improvements, Production Management, Quality Management, Quality Risk Assessment, Regulatory Compliance, Right First Time (RFT) {+ 5 more} Preferred Skills :