Role Summary:

The Plant Manager, reporting to the VP of Operations, is a pivotal leadership role responsible for manufacturing operations at our Le Sueur site. As Plant Manager, you will be responsible for the overall performance of the site, including Safety, Quality, Delivery, Cost, and People.  You will be driving operational excellence, ensuring compliance, and fostering a collaborative culture. Key responsibilities include managing capital and operational budgets, maintaining highest service levels of product delivery, overseeing logistics, and driving continuous improvement in a pharmaceutical manufacturing environment. This position requires alignment with corporate strategy, adherence to cGMP and regulatory compliance, and implementation of site-specific strategies.

The ideal candidate is a collaborative, performance-oriented individual capable of leading change. This role requires a balance of strategic leadership and hands-on involvement in day-to-day operations. The Plant Manager will lead with visionary leadership, innovation, and a commitment to driving growth. Reporting directly to the Plant Manager are the Production Managers, Facility Maintenance Manager, Warehouse Manager, and several individual contributors from support functions.

Job Requirements:

Leadership & Strategic Oversight

• Provide overall leadership and direction for the plant, aligning operations with company goals and objectives.
• Develop and execute strategic plans to ensure the site meets production targets, quality standards, and financial goals.
• Serve as the primary site leader, ensuring alignment with corporate expectations and policies.

Operational Management

• Oversee all operational functions, including production, quality assurance, maintenance, supply chain, and regulatory compliance.
• Monitor key performance indicators (KPIs) and implement continuous improvement initiatives to enhance efficiency, safety, and product quality.
• Manage the site budget, ensuring cost-effective operations and optimal resource allocation. Culture Development
• Drive a high-performance culture with accountability for performance goals and site KPIs.

• Lead cultural and organizational change, implementing operational excellence and lean manufacturing.
• Establish individual goals aligned with corporate/departmental objectives, coach, and review performance.

Financial Management

• Achieve financial objectives by forecasting, budgeting, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Develop and implement the site’s strategic 5-year business plan, budget, long-range goals, and vision for manufacturing operations.
• Ensure resources are available to meet the company’s growth requirements.
• Manage product cost drivers, overall cost ownership, risk management, and ongoing cost improvements.

Quality and Compliance

• Maintain GMP standards to ensure regulatory and client inspection readiness.
• Promote a culture of Right First Time/Safety First, ensuring compliance with cGMP regulations.
• Maintain buildings, infrastructure, manufacturing lines, and equipment to standards.
• Ensure quality investigations into batch discrepancies and out-of-specification events, maintaining compliance.

Environmental Health and Safety Performance and Culture

• Develop and implement safety programs and initiatives to enhance safety performance.
• Conduct regular safety audits, risk assessments, and safety drills to ensure a safe working environment.
• Foster a safety-first culture, ensuring all employees are trained in safety protocols and best practices.
• Investigate and address safety incidents promptly, implementing corrective actions to prevent recurrence.
• Collaborate with safety committees and employees to identify and mitigate potential hazards.

Continuous Improvement

• Adapt and implement best practices and lean-continuous improvement methods.
• Examine equipment, processes, operations, and packaging.
• Maintain and publish KPIs to measure success and drive continuous improvement.
• Ensure consistent product delivery and resolve complex manufacturing issues.

Project Management

• Act as a key stakeholder in New Product Introduction and CAPEX projects, ensuring operational requirements are met.
• Coordinate site-wide facility audits by customers, FDA, and EU, and respond to corrective actions as required.

Collaborative Communication

• Communicate issues, risks, and discrepancies to senior management, offering solutions.
• Drive culture change through front-line management, ensuring effective operational delivery.
• Coordinate with Quality Assurance and Quality Control to ensure timely testing and release of raw materials and final products.

Key Competencies:

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts.Exhibit willingness to listen and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.

FINANCIAL ACUMEN – is the ability to maintain and apply a broad understanding of financial management principles to ensure decisions are fiscally sound and responsible. Demonstrates broad understanding of financial management principles to direct organizational activities.

PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.

LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high-performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission.Provides direction with purpose and alignment to Company mission, vision and values.

CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.

Qualifications:

• 10-15 years of experience in a highly regulated manufacturing facility specializing in solid and liquid dose manufacturing, with at least 10 years in a leadership role.
• Strong understanding of liquid and solid dose drug manufacturing and expertise in US FDA, and EU regulations.
• Relevant technical qualifications, including a university degree.
• Proven experience in leading and managing technical and non-technical teams to achieve manufacturing objectives.
• Experience in driving continuous and quality improvement initiatives.
• Leadership qualities to interface and communicate with all organizational levels.
• Experience in cross-functional environments and making decisions on manufacturing and supply chain priorities.
• Knowledge of parenteral drug manufacturing and regulations.
• Strong orientation towards quality and collaboration with Quality personnel.
• Experience in capital project execution within a manufacturing setting.
• Sound knowledge of Good Production Practices and Good Manufacturing Practice Guidelines.
• Excellent planning, organizational, communication, and leadership skills.
• Ability to manage multiple priorities and work under pressure.
• Strong problem-solving and analytical skills.
• Ability to thrive in a fast-paced and changing environment.
• Working knowledge of Continuous Improvement, Lean Manufacturing, and Operational Excellence principles.