Lewis & Clark Capital

The Plant Manager is a hands-on position responsible for the comprehensive oversight and strategic leadership of all manufacturing operations.  This includes production, environmental health and safety (EH&S), warehousing, maintenance, production planning, and supply chain management. The Plant Manager will plan, direct, and coordinate manufacturing activities to deliver first-time-right quality products that consistently meet or exceed customer expectations, stringent regulatory requirements (FDA, 21 CFR, cGMP, and OSHA), and shipping deadlines. They ensure all manufacturing processes adhere to efficient, compliant, and cost-effective standards while maintaining the highest levels of product quality, efficacy, and safety.

Specific responsibilities include, but are not limited to:

• Oversees the company’s profit and loss (P&L) statement.
• Oversees and manages the financial goals and health of departments and manages departmental budgets.
• Develop capital spending budgets for operations facilities and equipment, ensuring all projects are executed with a focus on cGMP compliance and completed in accordance with the budget.
• Develops, collaborates, and integrates a total strategy to drive plant operations, ensuring full compliance with FDA regulations, 21 CFR, and cGMP guidelines.
• Drives excellence in manufacturing, quality assurance, maintenance, warehousing, shipping & receiving, and operational standards (including facility hygiene/housekeeping) throughout the Plant.
• Investigates, develops, and recommends changes to processes and procedures to drive continuous improvement initiatives towards safe, compliant, quality, and efficient manufacturing.
• Oversees and maintains robust procedures for ensuring managers and supervisors have appropriate practices and controls in place to ensure safe, healthy working conditions for all employees, aligned with OSHA, cGMP, and FDA requirements.
• Works closely with Quality Assurance leaders to adhere to all required regulatory standards and support internal and external audits.
• Assess and analyze the plant's production processes, determining how to improve system efficiencies, remove current bottlenecks in a cash-efficient manner, while maintaining regulatory compliance.
• Drives continuous improvement within the Quality Management System (QMS), actively participates in and oversees the Management Review Team (MRT) to ensure effective implementation and maintenance of cGMP and regulatory compliance.
• Develops, implements, and ensures strict adherence to Standard Operating Procedures (SOPs) and batch production records that comply with cGMP requirements.
• Responsible for continuous shift evaluation and planning to meet customer demand, maintain optimal productivity, and avoid employee burnout and turnover.
• Direct and oversee material control for purchasing, warehousing, inventory control, and shipping to ensure quality, efficiency, cost control, and full traceability and compliance with cGMP requirements for raw materials and finished goods.
• Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees.
• Drives profitability by managing Costs of Goods Sold, Gross Profit, and EBITDA.

Overall People Management Responsibilities:

• Garner increased employee engagement by developing and leading staff through active coaching and training, including thorough cGMP and quality system training, while cultivating a collaborative, cross-functional team, fostering a culture of accountability, creative problem solving, and results-driven operations within a regulated context.
• Responsible for recruiting, retaining, and developing top talent.

SKILLS & EDUCATIONAL REQUIREMENTS:

• BA/BS in Engineering (Chemical, Mechanical, Industrial), Chemistry, Pharmacy, or a related scientific/technical field preferred; equivalent experience considered.
• 8+ years progressive experience in manufacturing operations, with a significant portion in FDA-regulated industries (e.g., pharmaceutical, medical device, or OTC consumer products).
• 5+ years of management within an FDA-regulated manufacturing facility.
• 3+ years of working in and managing a robust Quality Management System (QMS) in a cGMP environment, with direct experience in 21 CFR compliance.
• Superior analytical ability and attention to detail.
• Excellent interpersonal skills; demonstrated ability to effectively interact with all levels within the organization, including regulatory bodies.

PREFERRED SKILLS:

• Liquid fill manufacturing experience (personal care and OTC).
• Experience in rapidly expanding plant capacity via shift expansions, including validation activities.
• Bilingual (Spanish) skills.