Senior Specialist, Drug Product Operations - Wilmington Biotech

Overview

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. 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 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. 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 treatment—one molecule at a time.

We invite you to become a part of our journey as the Manufacturing Senior Specialist 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 Senior Specialist will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T the Manufacturing Senior Specialist will provide comprehensive manufacturing and technical leadership to the drug product organization.

• Actively engage with the engineering design firm in detailed design on all aspects of the drug product manufacturing.
• Active participation in 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.
• 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 sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated).
• Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing.
• Support technical deliverables within Drug Product to support the successful product launch.
• Promote a Safety First, Quality Always mindset with Inclusion for all, fostering a Right First Time Culture.
• Provide technical support for RFT implementation and execution.
• Explain complex technical issues to external customers / agencies.

• Bachelor’s degree in engineering, science or related discipline.

• Five or more (5+) 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.
• Ability to 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 placebo runs, developmental batches and PPQ runs.
• Exp…