Description
CPC Scientific (CPC) is a globally recognized and leading CDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. CPC works directly with leaders in the biotechnology and pharmaceutical industries to bring life-changing therapeutics and diagnostics to market ranging from early drug discovery stages through clinical trials to commercial 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.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
DUTIES:
Site Business & Strategic Leadership
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 escalate 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.
Manufacturing & CDMO Production Oversight
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.
Site Quality and Regulatory Compliance
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 21CFR, 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.
Facilities, Capital Project & EHS Governance
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 OSHA-compliant workplace safety, EPA hazardous waste/emission control and emergency response frameworks;
Schedule regular safety rounds and emergency drills to eliminate fire, chemical and cleanroom operational hazards;
Oversee facility validation and equipment IQ/OQ, collaborate with quality teams to maintain utility GMP compliance.
Supply Chain, Procurement & Cross-Functional Collaboration
Oversee end-to-end site supply chain including procurement, inventory, warehouse and cross-border import/export logistics to guarantee stable supply of peptide APIs, reagents, instruments and packaging;
Supervise supplier qualification, on-site audits and performance review to mitigate single-source supply risks;
Collaborate with Validation & Engineering teams on equipment and raw material procurement for new process transfers;
Partner with Finance on payment & cost accounting, align with HR on employee related matters;
Administer site admin, IT and support functions to backstop core manufacturing & quality operations.
Team Leadership & Continuous Improvement
Build, mentor and motivate site leadership and staff, establish management succession pipeline;
Set department head performance targets and conduct regular performance reviews & career development discussions;
Cultivate site culture focused on safety, compliance, customer focus and operational excellence;
Deploy Lean, Six Sigma and other continuous improvement initiatives to cut risks and overall operating costs;
Maintain confidentiality protocols to protect proprietary peptide processes, client formulas and core business data; complete other ad-hoc overseas site assignments from global leadership.
Competencies
Business Acumen: End-to-end P&L decision-making, balance production demand, compliance risk and commercial profit;
Regulatory Risk Forecasting: Proactively mitigate major FDA/EPA/OSHA violations under US multi-agency oversight;
Greenfield Project Leadership: Align timeline, quality and cost across construction, validation and trial production phases;
Leadership: Motivate, resolve conflicts and retain management team;
Executive Communication: C-level negotiation with global pharma clients & formal reporting to corporate global leadership;
Other Duties:
Other duties as assigned.
Essential Physical and Mental Requirements
Physical Requirements:
§ Ability to sit at a desk for extended periods.
§ Ability to extend on-site office hours during the week/weekends when needed for executive meetings, business & capital document drafting, construction & commissioning.
§ Ability to extensively use computer keyboard, mouse and monitor.
§ Ability to lift at least 25 +/- pounds.
§ Ability to work in a venue such as a lab, office environment, hotel/conference room, etc., with the possible inclusion of working on the weekends.
§ Ability to have regular access to cleanrooms, equipment rooms and hazardous waste zones with full PPE.
§ Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, etc, as well as, conduct full-site walkthroughs.
Mental Requirements:
§ Ability to work with frequent interruptions and changes in workload priorities and the ability to maintain confidentiality.
§ Ability to utilize excellent analytical and organizational skills.
§ Ability to manage multiple priorities and delegate responsibilities while maintaining quality.
§ Ability to be an independent, self-motivated individual, working in a fast-paced team environment with tight schedules.
§ Ability to utilize strong written and verbal communication skills, being responsive in a timely manner and able to work effectively as part of a team.
Ability to exhibit proficient knowledge and use of English communication skills, e.g., reading, writing and speaking.
Travel:
Valid drivers’ license and insurance required.
Ability to travel domestically by car or commercial means up to 10% of the time. Valid passport is required and ability to travel to China, if needed.
Other:
The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive. This job description may be modified at any time as needed.
CPC is an equal-opportunity employer. A pre-employment background check will be required.
Requirements
Qualifications:
Education:
Master’s degree in Organic Chemistry, Peptide Chemistry, Pharmaceutical Engineering or BioPharma is required. Ph.D. degree is preferred; Certificates in OSHA 30, GMP Internal Auditor, US Pharmaceutical compliance training certificates preferred.
Work Experience:
12+ years end-to-end GMP peptide/API CDMO comprehensive management experience;
Minimum 5 years full site General Manager track record at a pharma facility;
Mandatory greenfield GMP plant launch experience covering construction, validation, trial batches to full commercial production;
In-depth, comprehensive knowledge of FDA, EU GMP, OSHA, EPA US local regulatory landscape, proven track record leading full-site FDA inspections;
Extensive capacity planning, process scale-up and multi-client CDMO program oversight for commercial peptide synthesis & purification;
Hands-on full P&L ownership, annual CAPEX/OPEX budgeting and cost optimization experience;
Experience building a workforce in the USA of 100+ employees and managing site leadership team;
Expertise in ERP, LIMS, project management, budgeting software and MS Office Suite.
