Associate Director, Drug Product Operations – Wilmington Biotech

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, a bold step forward in transforming cancer care through innovation, collaboration, and purpose‑driven science.

The Manufacturing Associate Director will play a pivotal role in ensuring the smooth operation of manufacturing activities. In partnership with site M&T, you will provide comprehensive manufacturing and technical leadership to the drug substance organization, guiding the development of a state‑of‑the‑art GMP facility.

• Lead and engage the engineering design firm on detailed design for all aspects of drug product manufacturing.
• Lead Process Hazard Analyses and Quality Risk Assessments as needed.
• Participate actively in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Execute automation sprints for the drug product area.
• Support equipment qualification deliverables (Commissioning & Qualification, IOQ, etc.).
• Perform process and facility fit activities to enable engineering and qualification of new products.
• Provide manufacturing and technical expertise within the team (sterile supply, formulation, isolation, filling, lyophilization, capping, visual inspection).
• Support technical deliverables for successful technology transfer.
• Lead change controls and quality documents for new product introduction.
• Conduct work with strict adherence to safety and compliance culture.
• Support authoring of electronic batch records, sampling plans, and SOPs.

• Bachelor’s degree in engineering, science, or related discipline.
• Eight or more years of cGMP experience in a biological, vaccine, or pharmaceutical facility.
• Experience in aseptic manufacturing and new facility operational readiness.
• Experience with facility, equipment, and process design.
• Expertise in sterile supply, formulation, isolation, filling, lyophilization, capping, and visual inspection.
• Ability to lead and operate within a matrix team for FAT, SAT, IQ/OQ, and engineering batches.
• Experience with CQV activities and data‑driven root cause analysis.
• Familiarity with risk‑based manufacturing tools such as FMEA.
• Understanding of USP 1790 and industry/regulatory requirements such as Annex 1.
• Strong planning, communication, and technical writing skills.

• Startup experience in a large‑scale commercial drug product facility.
• Experience with AVI/MVI and creation of a defect library.
• Experience with placebo, developmental, and PPQ runs.
• Lean Six Sigma or continuous improvement background.

• Adaptability, Antibody Drug Conjugates, Aseptic Processing, Communication, Cross‑Cultural Awareness, Customer‑Focused, Engineering Design, Freeze Drying, GMP Compliance, Leadership, Lean Six Sigma, Manufacturing Quality Control, New Product Introduction, Organizational Compliance, Pharmaceutical Manufacturing, Process Improvements, Production Management, Quality Management, Regulatory Compliance, Right First Time.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three on‑site days per week (Monday‑Thursday, with specific days varying by site) and a remote day on Friday, unless business critical tasks require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions, collective‑bargaining‑agreement positions without hybrid provision, or roles designated as fully remote.

Salary range: $ – $, based on education, experience, and other factors. Eligible for annual bonus and long‑term incentive. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

Apply through the Workday Jobs Hub or provided link. The Final date to receive applications is provided on the posting. The job posting ends on 11/29/2025.

MSD