Plant Manager

We are seeking a highly motivated Plant Manager to be responsible for the overall leadership, safety, and performance of a cGMP manufacturing facility, including production, quality, maintenance, and site compliance functions. This role ensures the site consistently meets production targets, quality standards, and regulatory requirements (cGMP, FDA, OSHA) while driving continuous improvement in safety, efficiency, and cost performance. This hands‑on position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position.

• Direct day‑to‑day manufacturing operations to meet production schedules, yield targets, and cost budgets.
• Oversee capacity planning, batch scheduling, and resource allocation across production teams.
• Drive Overall Equipment Effectiveness (OEE), right‑first‑time rate, and cycle time improvements.
• Ensure adequate staffing, shift coverage, and cross‑training across production areas.

• Maintain full compliance with current Good Manufacturing Practices (cGMP), SOPs, and batch record requirements.
• Partner with Quality Assurance on deviation investigations, CAPAs, change controls, and audit readiness.
• Serve as a site leader during FDA, customer, and internal audits/inspections.
• Ensure timely, accurate documentation practices (data integrity, ALCOA+ principles).

• Champion a strong safety culture; own site safety metrics (TRIR, near‑miss reporting, corrective actions).
• Ensure compliance with OSHA, EPA, and other applicable environmental and safety regulations.
• Lead incident investigations and implement preventive/corrective measures.

• Lead, coach, and develop production supervisors, shift leads, and manufacturing staff.
• Set performance goals, conduct evaluations, and manage disciplinary actions in partnership with HR.
• Foster cross‑functional collaboration with Quality, Supply Chain, Engineering, and R&D.
• Build succession plans and talent pipelines for key production roles.

• Identify and lead Lean/Six Sigma or similar continuous improvement initiatives.
• Manage capital projects, equipment upgrades, and facility expansions in coordination with Engineering.
• Develop and manage the site’s annual operating budget and capital expenditure plans.
• Report site KPIs (throughput, yield, quality, safety, cost) to executive leadership.

• Bachelor's degree in Engineering, Biology, Chemistry, or related technical field (or equivalent experience)
• 8+ years of progressive manufacturing leadership experience, including 3+ years in a plant/site manager or senior operations leadership role
• Direct experience operating within a cGMP‑regulated environment (biotech, pharma, or related life sciences manufacturing)
• Must have prior experience in a specialty ingredient manufacturing, chemical, or bio‑processing plant
• Strong working knowledge of FDA regulations, batch record systems, and quality management systems
• Demonstrated success managing P&L, budgets, and capital projects
• Proven people‑leadership skills with experience managing multi‑shift teams
• Excellent communication skills; both oral and written are required.
• Strong analytical and problem‑solving skills are required.
• Computer skills and an in‑depth knowledge of Microsoft Windows based programs are required.
• Ability to work flexible hours.
• Requires effective time management skills, personal conduct, and change management abilities.
• Ability to effectively interact with co‑workers, vendors, contractors and other business contacts.
• Must…