Senior Specialist, Drug Product Operations

Merck • Wilmington, DE

2d • $96,200 - $151,400 • Onsite

About The Position

The Manufacturing Senior Specialist, Drug Product will contribute to the development of Merck’s new antibody-drug conjugate manufacturing facility in Wilmington, Delaware, and help ensure successful GMP manufacturing. In partnership with site MS&T, the role provides manufacturing and technical leadership to the drug product organization, supporting equipment and process readiness, product launch, engineering and qualification activities, and commercial manufacturing. The role supports drug product operations involving sterile supply, formulation, isolators, filling, lyophilization, capping, and visual inspection. It promotes a Safety First, Quality Always mindset, inclusion, and a Right First Time culture. The position is based in Wilmington, Delaware, has a 25% travel requirement, and involves highly potent compounds.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline.
• At least 5 years of experience working in a cGMP biological, vaccine, or pharmaceutical facility.
• Ability to work within a matrix team and execute floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
• Previous experience providing manufacturing and technical support for placebo runs, developmental batches, and PPQ runs.
• Experience with AVI/MVI and creation of a library of defects.
• Experience with formulation, sterile supply, filling, and lyophilization unit operations.
• Experience using data-driven root cause analysis and prioritizing continuous improvement initiatives, such as Six Sigma.
• Experience using risk-based manufacturing tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.
• Understanding of USP 1790 and industry and regulatory requirements such as Annex 1.
• Demonstrated planning, oral and written communication, and technical writing skills.
• Skills in aseptic manufacturing, batch production, equipment qualification, GMP documentation, pharmaceutical formulations, plant startup, root cause analysis, sterile filling, sterile manufacturing, and visual inspections.

Nice To Haves

• Prior aseptic manufacturing experience in a cGMP biological, vaccine, or pharmaceutical facility.
• Start-up experience in a large-scale commercial drug product facility.
• Previous experience with Commissioning, Qualification, and Validation (CQV) activities.
• Skills in cGMP regulations, drug product manufacturing, and fill and finish.

Responsibilities

• Participate in Process Hazard Analyses and Quality Risk Assessments as needed.
• Participate in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Execute automation sprints in the drug product area as needed.
• Support equipment qualification deliverables during project execution, including Commissioning & Qualification and IOQ.
• Create and revise technical documents, including manufacturing batch records, SOPs, and technical memos.
• Provide manufacturing and technical expertise across sterile supply, formulation, isolators, filling, lyophilization, capping, and manual and automated visual inspection.
• Execute engineering batches, Process Performance Qualifications, and commercial manufacturing.
• Support Drug Product technical deliverables for successful product launch.
• Promote a Safety First, Quality Always mindset, inclusion, and a Right First Time culture.
• Provide technical support for Right First Time implementation and execution.
• Explain complex technical issues to external customers and agencies.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior