Manager, Operations

Thermo Fisher Scientific•Greenville, NC

About The Position

Lead strategic and day-to-day sterile formulation and filling operations, ensuring the production schedule is executed safely, compliantly, efficiently, and reliably. Provide direct leadership to manufacturing supervisors and/or production teams, coordinating with Quality, MSAT, Engineering, Supply Chain, Maintenance, and other support functions to deliver high-quality products and meet customer commitments and business objectives. The role focuses on achieving safety, quality, delivery, productivity, and financial targets through operational excellence and continuous improvement. It involves maintaining a strong floor presence, managing operational risks and barriers, supporting staffing, training, equipment readiness, and material availability, and reviewing and approving manufacturing documentation and quality records. The Manager also supports product introductions, process changes, equipment improvements, and manufacturing readiness, while building a culture of safety, quality, accountability, collaboration, continuous improvement, and employee engagement. The successful candidate is a visible, engaged leader who develops teams, sets clear expectations, applies technical understanding and structured problem solving, and delivers results while protecting safety, product quality, compliance, and employee development. The work is performed under GMP and cleanroom requirements and requires appropriate personal protective equipment.

Requirements

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.
Demonstrated experience leading manufacturing teams and frontline leaders.
Strong understanding of GMP manufacturing and quality systems.
Strong communication, problem-solving, organizational, and decision-making skills.
High interpersonal skills to establish and maintain effective working relationships with employees and customers, including tact in handling critical matters.
Ability to motivate, energize, and retain key staff through direct interactions with supervisors and staff.
Ability to balance multiple ongoing activities and prioritize tasks.
Ability to work in a cleanroom under GMP safety standards and comply with restrictions on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair; some PPE is required.

Nice To Haves

Five or more years of operations experience in pharmaceutical manufacturing or a related industry.
Two or more years of leadership experience.
Experience with formulation, compounding, aseptic filling, or sterile manufacturing.
Experience with Lean, Six Sigma, Practical Process Improvement, or similar continuous-improvement methodologies.

Responsibilities

Lead day-to-day formulation and filling operations to achieve safety, quality, delivery, and productivity objectives.
Ensure manufacturing activities comply with GMP requirements, site procedures, and safety standards.
Provide direction, coaching, and development to supervisors, leads, and production personnel.
Maintain a 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, risk assessments, and change controls.
Partner with Quality and technical teams to resolve deviations, investigations, CAPAs, and manufacturing issues.
Establish and monitor operational performance and improve 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.
Balance multiple ongoing activities and prioritize tasks in aseptic processing operations.
Interact with customers in the commercial operation of the described lines and handle customer and regulatory interactions effectively.
Coordinate cross-functional activities to meet customer commitments and business objectives.