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Senior Specialist, Drug Product Operations

Merck Wilmington, DE

Wilmington, DE

Today

$96k - $151k/yr Full time Senior Gmp (good Manufacturing Practices) Product Operations

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Job Description

Merck is hiring a Manufacturing Senior Specialist for Drug Product Operations at its Wilmington, DE ADC manufacturing facility. In this onsite role, you will provide manufacturing and technical leadership to help ensure successful GMP drug product manufacturing and to support product launch deliverables across multiple sterile drug product unit operations.

Working in a matrix environment, you will collaborate with cross-functional partners on testing, qualification, documentation, and execution of engineering activities, with a focus on right-first-time quality and safety.

What you’ll do

Participate in Process Hazard Analyses and Quality Risk Assessments as needed.
Support factory acceptance testing (FAT) and site acceptance testing (SAT).
Execute automation sprints within the drug product area as necessary.
Support equipment qualification deliverables during project execution, including commissioning & qualification and IOQ (as applicable).
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 visual inspection (manual and automated).
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 with inclusion and support a Right First Time culture.
Provide technical support for RFT implementation and execution.
Explain complex technical issues to external customers and agencies.

Required qualifications

Bachelor’s degree in engineering, science, or related discipline.
5+ years working in a cGMP biological, vaccine, or pharma facility.
Experience operating within a matrix team to execute on-floor activities including FAT, SAT, IQ/OQ, and Engineering batches.
Experience supporting manufacturing and technical work 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.
Ability to adapt to changing priorities as project demands shift.
Understanding of USP1790 and industry/regulatory requirements such as Annex 1.
Demonstrated skills in planning and communication, including technical writing.
Data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (for example, Six Sigma).
Risk-based approach to manufacturing using tools such as FMEA.

Preferred qualifications

Prior cGMP experience in biological, vaccine, or pharma facilities with aseptic manufacturing experience.
Experience with CQV activities.
Experience with drug product manufacturing.
Experience with fill and finish.

Technologies and tools

Six Sigma
FMEA
AVI/MVI
USP1790
Annex 1
IOQ

Compensation and benefits

Salary range: USD 96,200 - 151,400 per year (primary location: Wilmington, DE).
Medical, dental, and vision healthcare and other insurance benefits for employee and family.
Retirement benefits including 401(k).
Paid holidays, vacation, compassionate and sick days.
Annual bonus and long-term incentive, if applicable.

Additional details: Onsite role in Wilmington, Delaware, USA (Biotech). Travel requirement: 25%. Employment status: Regular. Relocation: No. Visa sponsorship: No. Flexible work arrangements: Not Applicable. Shift: Not Indicated. Primary location: USA - Delaware - Wilmington. Hazardous materials: highly potent compounds. Job posting end date: 11/23/2026. Requisition ID: R425668.

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