Associate Director, Manufacturing - Sterile Fill/Finish (Relocation Available)
The Opportunity
Hydrogen Group has partnered with a growing injectable drug product CDMO to find an Associate Director of Manufacturing to lead its GMP fill/finish operations. This is a newly created leadership role with true end-to-end ownership of aseptic operations - the kind of build-and-shape mandate you rarely get at a large, established site. If you want a real voice in how a high-growth sterile manufacturing operation scales, this is it.
Our client specializes in injectable drug product development and manufacturing across both clinical and commercial programs - vial and syringe fill/finish, liquid and lyophilized formulation, process development, PPQ/PV, labeling, and packaging. They've grown significantly over the past two years and are investing in their leadership bench.
What You'll Own
You'll lead and develop the manufacturing team while serving as the aseptic operations SME - filling, preparation (washing, autoclaving, formulation), and the supporting processes around them. You'll drive validation activities (engineering batches, aseptic process simulation, qualification protocols), own production schedule adherence, build operator training and qualification programs, and ensure the operation is compliant and defensible to regulatory agencies. You'll also author and review the documentation backbone of the operation - Master Batch Records, SOPs, deviations, CAPAs, and change controls and keep the team inspection-ready at all times.
What We're Looking For
- 10–12 years of pharmaceutical manufacturing experience, with 5+ years in a leadership role
- Strong hands-on knowledge of drug product / sterile fill-finish technologies: vial lines (stoppering and capping), syringe lines within RABS, cartridge lines, and manual filling
- Deep cGMP expertise and working knowledge of FDA, DEA, and international regulations
- Demonstrated experience with aseptic process simulation/media fills, equipment qualification, and validation
- Proven people leadership - training, mentoring, and supervising manufacturing personnel
- BS in Chemical Engineering, Biology, or a related life science (MS preferred), or equivalent relevant experience
The Details
- Base salary: $170,000–$185,000, depending on experience, plus a full benefits package
- Relocation assistance provided for the right candidate
- On-site in Orange County, CA - a strong market for the industry with a lot to offer
Interested, or know someone who'd be a fit? Apply here or reach out directly to discuss in confidence.
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