Manager, Operations (Mon-Fri Nights)

Thermo Fisher Scientific•Greenville, NC

1d•Onsite

About The Position

As the Operations Manager for Sterile Manufacturing, you will lead the compounding, dispensing, and aseptic filling operations within Sterile Production. This role is critical to ensuring high-quality, compliant pharmaceutical manufacturing that supports both clinical and commercial supply. You will provide both technical and administrative leadership, ensuring that Good Manufacturing Practices (GMP) and Thermo Fisher Scientific Quality Systems requirements are consistently met while delivering production targets safely, efficiently, and cost-effectively. This position plays a key leadership role in commercial sterile operations and serves as an important interface with customers and regulatory authorities.

Requirements

Bachelor’s degree in Engineering, Science, Operations Management, or related field required. Equivalent combinations of education, training, and relevant experience may be considered.
Minimum 5+ years of pharmaceutical operations or quality experience required.
At least 2+ years in a significant management or leadership role required.
Strong technical and operational knowledge of aseptic processing and sterile manufacturing operations.
Working knowledge of GMP requirements and regulatory expectations within pharmaceutical manufacturing.
Understanding of cost control, production planning, and continuous improvement principles.
Excellent verbal and written communication skills with the ability to interact effectively at all organizational levels.
Strong organizational and time management skills with the ability to prioritize competing demands.
Demonstrated leadership and team development capabilities.
Strong analytical and problem-solving skills with the ability to evaluate and resolve complex technical challenges.
Ability to lead and motivate professional and operational staff to achieve production and quality goals.
Ability to delegate effectively and hold teams accountable.
Ability to work in a fast-paced, high-pressure environment.
Ability to identify and implement process improvement initiatives to enhance efficiency and reduce costs.
Ability to establish and maintain strong working relationships with employees, customers, and regulatory agencies.

Nice To Haves

Experience in sterile manufacturing, aseptic processing, or pharmaceutical/medical device environments preferred.
Experience in large pharmaceutical commercial manufacturing environments preferred.

Responsibilities

Lead day-to-day sterile manufacturing operations, including aseptic filling and isolator filling lines, and oversight of five freeze dryers (lyophilizers).
Maintain compliance within sterile production areas, ensuring GMP standards and quality system requirements are consistently met.
Coordinate and schedule filling activities to achieve budgeted production volumes and operational goals.
Provide technical and ethical oversight of ongoing operations, including troubleshooting and prioritization of multiple concurrent activities.
Monitor production efficiencies and implement process improvements to reduce variable standard costs and optimize cost of goods.
Ensure training programs are established and maintained; confirm personnel are appropriately trained and qualified.
Manage administrative aspects of the department, including performance planning, performance reviews, hiring, development, recognition, and disciplinary actions as needed.
Prepare and manage expense and headcount budgets to ensure adequate resourcing while meeting financial targets.
Foster a collaborative team environment that promotes accountability, engagement, and professional growth.
Support and actively promote site safety initiatives to maintain a safe and compliant work environment.
Serve as a key contact for customer interactions and support regulatory inspections and audits.
Comply with all job-related safety and training requirements.