Vice President, Peptide Manufacturing & Site Leadership GMP

Hartmann Young Limited; California; On-site; USD 420,000 - 640,000; Full time

Job summary

Hartmann Young Limited is seeking a senior manufacturing and site leader for a new GMP facility in Northern California. You will hold full site accountability from construction closeout to trial production and commercial launch, leading peptide manufacturing across synthesis, purification, fill-finish and packaging.

The role requires 12+ years in GMP peptide/CDMO leadership, with 5+ years in top-site leadership, plus proven capability in plant launches, regulatory inspections and end-to-end site

Qualifications

• 12+ years of leadership in GMP peptide or API CDMO manufacturing.
• At least five years in a full-site General Manager or equivalent leadership position.
• Proven GMP plant launch experience from construction to commercial production.
• Strong knowledge of FDA, EU GMP, OSHA and EPA requirements.
• Hands-on ownership of site P&L, CAPEX, OPEX, budgeting and cost optimization.

Responsibilities

• Lead end-to-end clinical and commercial peptide manufacturing, including synthesis, purification, fill-finish and packaging.
• Own production scheduling and capacity planning across multi-client CDMO programs.
• Drive peptide process scale-up, technology transfer, and validation through commercial readiness.
• Maintain full site P&L accountability and oversee annual revenue, gross profit, OPEX and CAPEX targets.
• Lead regulatory readiness, audits, and continuous improvement of site quality and compliance.

Skills

Leadership

GMP/CDMO

P&L ownership

Regulatory inspections

Capacity planning

Education

Master's degree in Organic Chemistry/Peptide Chemistry/Pharmaceutical Engineering/Biopharmaceutical Sciences

Job description

A specialist peptide CDMO is appointing a senior manufacturing and site leader for a new GMP facility in Northern California. This is a high-impact executive position with full site accountability and P&L ownership, leading the facility from construction closeout and qualification through trial production and commercial launch.

Peptide manufacturing expertise is central to this appointment. The successful leader will oversee clinical and commercial peptide drug substance and drug product operations across synthesis, purification, fill-finish and packaging, while building the team, systems and culture required for a compliant, reliable and profitable CDMO site.

Key responsibilities

Peptide manufacturing and CDMO operations

• Lead end-to-end clinical and commercial peptide manufacturing, including synthesis, purification, fill-finish and packaging.
• Own production scheduling and capacity planning across parallel, multi-client and multi-product CDMO programs.
• Drive peptide process scale-up, technology transfer, process validation and cleaning validation through commercial readiness.
• Improve yield, material utilization, labor efficiency, on-time delivery and manufacturing cost performance.
• Partner with Quality on batch release, deviations, change controls and CAPA closure.

Site leadership and commercial performance

• Hold full site P&L accountability and own annual revenue, gross profit, OPEX and CAPEX targets.
• Lead the site lifecycle from greenfield closeout, equipment qualification and trial batches through stable commercial operation.
• Build and develop the site leadership team and wider workforce, establishing a strong succession and talent pipeline.
• Represent the site with senior pharmaceutical clients and resolve complex scheduling, delivery and quality matters.
• Lead executive business reviews covering delivery, quality, safety, cost and supply chain performance.

Quality regulatory facilities and EHS

• Maintain permanent inspection readiness across FDA, EU GMP, ICH, OSHA, EPA and applicable California requirements.
• Act as site lead for regulatory, third-party and client audits, including remediation of observations.
• Oversee cleanroom, laboratory and utility readiness, equipment IQ and OQ, preventative maintenance and facility validation.
• Hold ultimate accountability for site EHS, hazardous waste and emissions controls, emergency response and safe cleanroom operations.
• Establish a risk-based quality culture grounded in data integrity, operational discipline and continuous improvement.

Supply chain and organizational leadership

• Oversee procurement, inventory, warehousing and cross-border logistics for peptide APIs, reagents, equipment and packaging.
• Strengthen supplier qualification and performance management while reducing single-source supply risk.
• Align Manufacturing, Quality, Engineering, Validation, Finance, HR, IT and site support functions around launch and delivery priorities.
• Deploy Lean, Six Sigma and other continuous improvement methods to reduce risk and operating cost.

Required experience

• 12 or more years of leadership experience within GMP peptide or API CDMO manufacturing, with substantial direct exposure to commercial peptide synthesis and purification.
• At least five years in a full-site General Manager, Site Head, Operations Head, VP Manufacturing or equivalent leadership position.
• Demonstrated greenfield GMP plant launch experience spanning construction, validation, trial batches and commercial production.
• Proven leadership of FDA inspections and strong working knowledge of FDA, EU GMP, OSHA and EPA requirements.
• Strong experience in capacity planning, process scale-up and delivery of multi-client CDMO programs.
• Hands-on ownership of site P&L, CAPEX, OPEX, budgeting and cost optimization.
• Experience building and leading a US manufacturing organization of 100 or more employees.
• Master's degree in Organic Chemistry, Peptide Chemistry, Pharmaceutical Engineering, Biopharmaceutical Sciences or a related discipline. A PhD is preferred.

What will make someone stand out

The strongest candidates will combine deep peptide manufacturing knowledge with true site-level commercial ownership. They will have personally taken a GMP facility through commissioning and launch, led regulatory inspections, built high-performing teams and balanced client commitments with quality, safety, delivery and profitability.

Location and working pattern

This is a full-time onsite position based in Northern California. The role requires regular access to manufacturing, cleanroom, laboratory, equipment and utility areas. Some extended hours may be required during commissioning, launch activity, inspections and major client or executive meetings. Domestic and occasional international travel may be required.