Operations Director / VP of Facilities - Peptide CDMO

Reports to: CEO | Location: CA (100% onsite)

CDC are proud to be working with a globally recognised, leading CDMO specialising in synthetic peptide and oligonucleotide production, operating one of the largest research peptide facilities in the world. They work directly with biotech and pharma leaders to bring therapeutics and diagnostics from early discovery through clinical trials to commercial manufacturing.

They're building a brand-new GMP peptide manufacturing facility from the ground up, targeting commercial peptide production by Q4 2026/Q1 2027. This role is the top executive on site, with full P&L ownership - leading the site through construction closeout, equipment qualification, and trial production into stable commercial launch.

Key Responsibilities

Own full site P&L, set annual revenue/gross profit targets, and run executive business reviews
Act as senior liaison with corporate leadership and global pharma clients
Full accountability for peptide DS/DP manufacturing - synthesis, purification, fill-finish, packaging
Oversee capacity planning, technology transfer, and process validation across concurrent client programs
Own site-wide GMP compliance (FDA 21 CFR, EU GMP, ICH, USP, OSHA,EPA)
Unify QA and QC leadership under one site quality strategy
Serve as site lead for all FDA and client audits
Lead remaining construction, cleanroom/utility buildout, and capital projects through launch
Own EHS strategy and long-term preventative maintenance programs
Oversee procurement, inventory, and supplier qualification
Partner with Finance, HR, and Engineering on cost, staffing, and equipment decisions
Build and mentor the entire site leadership team from the ground up

Qualifications

Master's degree in Organic Chemistry, Peptide Chemistry, Pharmaceutical Engineering, or related field (PhD preferred)
12+ years of end-to-end GMP peptide/API CDMO management experience
5+ years as a full site General Manager with P&L accountability
Proven greenfield GMP plant launch experience - construction through validation, trial batches, commercial production
Deep knowledge of FDA, EU GMP, OSHA, and EPA regulatory frameworks
Track record leading full-site FDA inspections
Experience building a 100+ person US workforce and leading a site leadership team
Domestic travel up to 10%; valid passport required, occasional international travel possible

If you are interested in this role apply directly or reach out to harriet@cdcglobal.co.uk

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