Manager, Operations (Mon-Fri Nights)

Work Schedule

Environmental Conditions

Job Description

Operations Manager Nights Sterile Manufacturing & Aseptic Filling

Division/Site Specific Information Pharmaceutical Services Group (Greenville NC)

The Greenville NC site is a large multipurpose pharmaceutical manufacturing and packaging campus supporting both clinical and commercial production. The facility specializes in solid dose and sterile manufacturing including aseptic filling lyophilization biologics small molecules controlled substances and secondary packaging. With advanced technical capabilities and a strong global regulatory inspection history the site plays a critical role in delivering high-quality pharmaceutical products worldwide.

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges.

Discover Impactful Work:

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.

A Day in the Life:

• 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.

Keys to Success:

Education

• Bachelors degree in Engineering Science Operations Management or related field required.

• Equivalent combinations of education training and relevant experience may be considered.

Experience

• Minimum 5 years of pharmaceutical operations or quality experience required.

• At least 2 years in a significant management or leadership role required.

• Experience in sterile manufacturing aseptic processing or pharmaceutical/medical device environments preferred.

• Experience in large pharmaceutical commercial manufacturing environments preferred.

• Proven ability to lead teams manage budgets and drive operational efficiencies.

Knowledge Skills Abilities

Knowledge

• 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.

Skills

• 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.

Abilities

• 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.

Physical Requirements / Work Environment

Position requires ordinary ambulatory skills and physical coordination sufficient to move about production and office locations; ability to stand walk stoop kneel and crouch periodically for prolonged periods; ability to lift and carry light to medium weights (1035 pounds); arm hand and finger dexterity for operating equipment and typing; visual acuity to operate equipment and review documentation; and ability to sit reach talk and hear for extended periods.

Benefits

We offer competitive remuneration an annual incentive plan bonus healthcare and a comprehensive range of employee benefits. Thermo Fisher Scientific provides employment with an innovative forward-thinking organization and outstanding career and development prospects. Our culture stands for integrity intensity involvement and innovation.

Excellent Benefits Include:

• Medical Dental & Vision benefits effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

Relocation assistance not available

Must be legally authorized to work in the United States now and in the future without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.