Work Schedule

Environmental Conditions

Job Description

This position is responsible for the day-to-day operation of Sterile formulation and filling activities, ensuring safe, compliant, efficient, and reliable execution of the production schedule. This role provides direct leadership to manufacturing supervisors and/or production teams and works cross-functionally with Quality, MSAT, Engineering, Supply Chain, Maintenance, and other support functions to deliver high-quality product while maintaining a strong culture of safety, quality, accountability, and continuous improvement.

• Lead day-to-day formulation and filling operations to achieve safety, quality, delivery, and productivity objectives.
• Ensure manufacturing activities are performed in compliance with GMP requirements, site procedures, and safety standards.
• Provide clear direction, coaching, and development to supervisors, leads, and production personnel.
• Maintain strong floor presence and proactively identify and resolve operational risks and barriers.
• Ensure appropriate staffing, training, equipment readiness, and material availability to support the production schedule.
• Review and approve investigations, master batch records, protocols and associated summaries, procedures, risks assessments, change controls, etc.
• Partner with Quality and technical teams to resolve deviations, investigations, CAPAs, and manufacturing issues.
• Establish and monitor operational performance and drive improvements in schedule adherence, right-first-time execution, yield, cycle time, and productivity.
• Drive structured problem solving, standard work, and continuous improvement using Lean, Practical Process Improvement, or similar methodologies.
• Support new product introductions, process changes, equipment improvements, and manufacturing readiness activities.
• Build a culture of safety, quality, accountability, collaboration, continuous improvement and employee engagement.
• Possess technical and operational knowledge of aseptic processing operations, demanding the ability to balance multiple ongoing activities and prioritize tasks. Interact with customers in the commercial operation of the described lines and handle customer and regulatory interactions effectively.

How will you get here?

Education

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations, or a related field.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Experience

• 5+ years of operations experience in pharmaceutical manufacturing or a related industry is preferred.
• 2+ years leadership experience preferred.
• Demonstrated experience leading manufacturing teams and frontline leaders.

Knowledge, Skills, Abilities

• Strong understanding of GMP manufacturing and quality systems.
• Strong communication, problem-solving, organizational, and decision-making skills.
• Experience with formulation, compounding, aseptic filling, or sterile manufacturing is preferred.
• Experience with Lean, Six Sigma, Practical Process Improvement, or similar continuous-improvement methodologies is preferred.
• High level of interpersonal skills to establish and maintain effective working relationships with employees and customers; including tact to handle critical matters.
• Ability to motivate, energize, and retain key staff through direct interactions with supervisors and staff.

The ideal candidate is a visible and engaged operations leader who develops strong teams, sets clear expectations, and drives disciplined execution. They combine technical understanding with strong people leadership, use data and structured problem solving to address issues, and work effectively across functions.

Success in this role requires the ability to consistently deliver results while protecting safety, product quality, compliance, and employee development.