Senior Specialist, Drug Product Operations

MSD•Wilmington, DE

15h•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 and supports facility start-up, product launch, engineering and qualification activities, and commercial production. The position covers sterile supply, formulation, isolators, filling, lyophilization, capping, and manual and automated visual inspection. The specialist works across a matrix team to execute floor activities and technical deliverables, promote a Safety First, Quality Always and Right First Time culture, and provide technical support for RFT implementation. The role may also involve explaining complex technical issues to external customers and agencies. The primary location is Wilmington, Delaware. The position has a 25% travel requirement, no relocation assistance, and no visa sponsorship. The shift is not indicated; flexible work arrangements are listed as not applicable. Hazardous materials include 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.
Experience supporting manufacturing and technical activities for placebo runs, developmental batches, and PPQ runs.
Experience with AVI/MVI and creating 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.
Ability to apply a risk-based approach to manufacturing using 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.

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.
Experience with cGMP regulations, drug product manufacturing, and fill and finish.

Responsibilities

Participate in Process Hazard Analyses and Quality Risk Assessments as necessary.
Participate in factory acceptance testing (FAT) and site acceptance testing (SAT).
Execute automation sprints in the drug product area as necessary.
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 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.