Operations Head or VP of Manufacturing

CPC is seeking an Operation Head or VP of Manufacturing to fill a full-time, onsite position in our Rocklin, California facility. This position will report directly to the CEO.

This position is considered as a top executive with full P&L ownership in the new GMP peptide CDMO facility to guarantee long-term compliant, profitable and stable site operation. This position is responsible for end-to-end overall accountability for site business performance, commercial peptide manufacturing, full‑site quality compliance, capital construction & facility maintenance, global supply chain, EHS management, team leadership, budget control, client and regulatory liaison.

This position will lead the full site lifecycle from construction closeout, equipment qualification, trial production through stable commercial launch in Q4 2026. In addition, this position will align with corporate business strategy, formulate annual site targets, CAPEX & OPEX budgets, as well as, maintain permanent inspection readiness for FDA, OSHA, EPA and all client/regulatory audits. The position will build local leadership team, oversee on‑time delivery of commercial peptide synthesis, purification and fill‑finish CDMO programs.

Also will be responsible for the five core site goals – safety, environmental compliance, quality, on‑time delivery and cost efficiency. This position will balance client commitments, regulatory risk and operational profitability, establish sustainable talent pipeline and risk‑based quality & safety culture.

• Execute corporate global peptide CDMO strategy, develop medium‑long term site roadmap, annual revenue & gross profit targets
• Hold full site P&L accountability, formulate, approve and execute yearly OPEX & CAPEX budgets, continuously optimize manufacturing, capital and labor costs
• Lead monthly/quarterly site executive business reviews to track delivery, quality, safety, cost and supply chain KPIs, identify business risks and drive corrective actions
• Liaise with corporate senior leadership of Operations, Finance and Commercial, submit regular site business performance reports and elevate major projects, audits, safety & compliance events
• Interface with senior stakeholders of global pharma clients, coordinate large‑scale project scheduling, delivery and quality disputes to boost client retention & satisfaction

• Full oversight of clinical and commercial peptide DS/DP manufacturing workflows: synthesis, purification, fill‑finish and packaging
• Oversee production scheduling and capacity planning to deliver parallel multi‑client, multi‑product CDMO orders on schedule
• Ensure manufacturing strictly follows approved processes & batch records, coordinate with QA on batch release, production deviations, change control and CAPA closure
• Drive technology transfer, process validation and cleaning validation, resolve bottlenecks for large‑scale peptide commercial production
• Monitor yield, material loss and labor efficiency goals to continuously boost manufacturing productivity

• Full ownership of site GMP compliance, provide unified leadership to QA Director and QC Director, oversee lab, manufacturing and document QMS operation
• Ensure all site activities comply with FDA 21
  
  CFR, EU GMP, ICH, USP, OSHA, EPA and California local environmental & building codes
• Site lead for all FDA, third‑party and client audits, coordinate document preparation, site walkthrough and full observation remediation
• Roll out site‑wide ALCOA+ data integrity and ICH Q9 risk assessment plus continuous quality improvement programs
• Approve critical site quality documents, quality agreements and regulatory submission materials, resolve cross‑functional major quality matters

• Lead all greenfield closeout, cleanroom, lab and utility (HVAC/WFI/gas) construction, renovation and expansion capital projects for Q4 2026 launch
• Direct facilities team to establish standardized preventative maintenance program for long‑term stable peptide production equipment & utilities
• Hold ultimate site EHS accountability, build…