Job Description

🚀 Welcome to the future of precision oncology—join us in Wilmington, DE!🚀
We’re launching a state-of-the-art Antibody-Drug Conjugate (ADC) manufacturing facility to advance cancer care through innovation, collaboration, and purpose-driven science. Our site will support both drug substance conjugation and drug product, meeting rising demand for high-potency manufacturing and ensuring resilient, GMP-ready supply.
We’re hiring a Manufacturing Senior Specialist, Drug Product. In this role, you’ll help stand up the facility and ensure successful GMP manufacturing—partnering with MS&T to lead across sterile supply, formulation, isolators, filling, lyophilization, capping, and visual inspection (AVI/MVI). You’ll contribute to design reviews, FAT/SAT, automation sprints, CQV (IQ/OQ/PPQ), engineering batches, technical documentation, risk assessments, and continuous improvement—driving a Safety First, Quality Always, Right-First-Time culture.

What we’re looking for:
– BS in engineering/science (or related)
– 5+ years in cGMP pharma/biologics/vaccines; aseptic experience preferred
– Start-up/large-scale drug product experience; CQV and PPQ exposure
– Hands-on with FAT/SAT, IQ/OQ, engineering and placebo/development batches
– AVI/MVI and defect library experience; data-driven RCA/Six Sigma; FMEA
– Familiarity with USP <1790> and Annex 1; strong technical writing and communication

This is more than a role—it’s an opportunity to shape the next wave of cancer treatment, one molecule at a time. Interested or know someone who is? Let’s connect. hashtag#MerckCareers hashtag#ADCManufacturing hashtag#PrecisionOncology
hashtag#Biopharma hashtag#PharmaManufacturing hashtag#cGMP hashtag#AsepticProcessing
hashtag#FillFinish hashtag#CQ

Apply to the following link: https://lnkd.in/eSW5cfS9