Vice President of Operations - Peptide CDMO

About the Role

CDC Global Solutions is collaborating with a world-renowned Contract Development and Manufacturing Organization (CDMO) specializing in synthetic peptides and oligonucleotides. Operating one of the largest research peptide facilities globally, they partner with top biotech and pharmaceutical companies to progress therapeutics and diagnostics from discovery through clinical trials to commercial-scale manufacturing. They are establishing a new GMP-compliant peptide manufacturing plant from the ground up, aiming for commercial operations starting Q4 2026 to Q1 2027. The Vice President of Operations will be the highest-ranking executive at this site, holding full responsibility for profitability, and guiding the facility through construction completion, equipment qualification, trial productions, and a smooth commercial launch.

Primary Responsibilities

• Manage comprehensive site profit and loss, define annual revenue and gross profit goals, and conduct executive-level business reviews.
• Serve as the primary intermediary between corporate leadership and international pharmaceutical clients.
• Take full ownership of peptide Drug Substance and Drug Product manufacturing operations, including synthesis, purification, fill-finish, and packaging.
• Supervise capacity planning, technology transfers, and process validations across multiple client projects.
• Ensure site-wide compliance with GMP standards, encompassing FDA 21 CFR, EU GMP, ICH, USP, OSHA, and EPA regulations.
• Integrate quality assurance and quality control leadership into a unified site quality management strategy.
• Lead all FDA and client audit activities at the facility.
• Oversee the conclusion of construction, cleanroom and utility setup, and capital equipment projects through to launch.
• Develop and implement environment, health, and safety (EHS) strategies alongside preventive maintenance plans.
• Manage procurement, inventory control, and supplier qualification processes.
• Collaborate with Finance, Human Resources, and Engineering departments on budgeting, staffing, and equipment procurement decisions.
• Assemble and mentor a complete site leadership team from inception onwards.

Candidate Qualifications

• Master's degree in Organic Chemistry, Peptide Chemistry, Pharmaceutical Engineering, or an associated discipline; PhD preferred.
• Over 12 years of comprehensive GMP peptide/API CDMO operational leadership experience.
• At least 5 years serving as a general manager with full-site P&L responsibility.
• Demonstrable experience leading greenfield GMP manufacturing facility launches including construction, validation, trial production, and commercial operations.
• Extensive knowledge of regulatory standards including FDA, EU GMP, OSHA, and EPA.
• Proven experience heading entire site FDA inspections successfully.
• Expertise in building and managing a US workforce of 100+ employees and cultivating a leadership team.
• Ability to travel domestically up to 10%, valid passport required, occasional international trips possible.