Senior Specialist, Drug Product Operations

MSD • 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 Wilmington, Delaware antibody-drug conjugate (ADC) manufacturing facility and help ensure successful GMP manufacturing. In partnership with site MS&T, this role provides manufacturing and technical leadership to the drug product organization and supports the facility’s development, product launch, and commercial operations.

The position provides technical expertise across drug product operations, including sterile supply, formulation, isolators, filling, lyophilization, capping, and manual and automated visual inspection. The specialist supports project-phase equipment commissioning and qualification, automation activities, engineering batches, process performance qualification (PPQ), and commercial manufacturing. The role also helps maintain a Safety First, Quality Always mindset, inclusion, and a Right First Time culture. The posting identifies Wilmington, Delaware as the primary location, lists 25% travel, and notes that the role 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 to execute floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
• Experience supporting manufacturing and technical activities 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 a risk-based manufacturing approach and tools such as FMEA.
• Ability to adapt as project priorities change.
• Understanding of USP 1790 and industry or regulatory requirements such as Annex 1.
• Demonstrated planning, oral and written communication, and technical writing skills.

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 CQV experience.
• Knowledge or experience 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 and 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 needed 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 (RFT) implementation and execution.
• Explain complex technical issues to external customers and agencies.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 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