Operations Leader

Role Purpose

The Operations Leader is responsible for providing operational leadership to the production of cell culture media and serum products. Reporting directly to the Plant Manager, the role drives plant management strategies and employs lean tools to improve safety, quality, efficiency, productivity, and unit cost. This position provides direction, vision, and supervision to plant operations team members, ensuring the achievement of safety, quality, delivery, and cost goals.

Key Responsibilities:

Operational Leadership:
Manage Production, Warehouse, Planning, Logistics, and Plant Facilities, ensuring smooth operations and efficiency. Lead shift leads and hourly teams with a focus on safety, quality, productivity, delivery, and cost. Oversee production schedules to meet targets while maintaining high standards. Drive continuous improvement through Lean and Six Sigma tools like Value Stream Mapping, Kaizen, and DMAIC. Develop and implement Sales, Inventory, and Operations Planning (SIOP) strategies for serum production, aligning demand, inventory, and operations.

Team Management and Development:
Recruit, interview, and hire hourly personnel, fostering growth through training programs and annual evaluations. Provide coaching, feedback, and development opportunities to align team skills with organizational goals. Promote a collaborative, team-oriented culture by leading by example, encouraging open communication, and fostering accountability. Motivate employees to achieve individual and team objectives while building a culture of trust and respect.

Quality and Compliance:
Ensure manufacturing aligns with ISO 13485 and FDA Quality System Regulations. Enforce adherence to Standard Operating Procedures (QOPs), Master Manufacturing Records (MMRs), and other critical practices. Implement standard operating procedures and enforce process discipline, ensuring consistency and compliance. Maintain rigorous change control and adherence to control set-points to mitigate risks and uphold high-quality standards.

Hands-On Leadership:
Actively participate in manufacturing processes, offering hands-on support for bulk production, troubleshooting, and addressing operational gaps. Provide formulation support and review to ensure accurate production processes. Lead real-time troubleshooting of equipment and process failures, collaborating with other departments to resolve issues efficiently. Step in when needed to maintain uninterrupted production and ensure high performance.

Process Improvement and Reporting:
Analyze production and financial reports to identify variances and develop improvement plans. Share key performance metrics with teams, plant staff, and leadership to drive transparency and informed decision-making. Lead New Product Development (NPD) programs for the plant, ensuring successful execution. Oversee internal and external Gamma Irradiation processes, ensuring compliance and efficiency. Provide guidance for the Reserves Management Program to optimize resource utilization.

By focusing on operational excellence, team development, quality compliance, hands-on leadership, and continuous improvement, this role drives the plant to meet organizational goals while maintaining high standards of safety, quality, and efficiency.

Experiences/Education - Required

• Bachelor’s degree (BS/BA), preferably in a biological or chemical science field.
• 3–5 years of operations experience in a manufacturing environment.
• Proficiency in MS Office (PowerPoint, Word, Excel).
• Strong analytical and problem-solving skills to address complex challenges.
• Ability to work independently in a dynamic business and manufacturing environment.
• A minimum of 5 years of supervisory or managerial experience leading teams.

Experiences/Education - Desired

• Ability to prioritize and manage multiple tasks effectively.
• Demonstrated ability to develop team members and provide constructive performance feedback.
• Basic knowledge of accounting principles.
• Lean and/or Six Sigma certification or experience.
• Strong project management skills.
• Excellent oral and written communication abilities.
• Adaptable and flexible in a fast-paced environment.
• Collaborative, team-oriented mindset.
• Customer-focused approach.