Manager, Manufacturing Control & Readiness

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions

Job Description

Manager, Aseptic Manufacturing & Lyophilization Operations

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.

Discover Impactful Work:

As part of the Thermo Fisher Scientific team, you will lead strategic and day-to-day aseptic manufacturing operations that directly impact patients around the globe. In this critical leadership role, you will drive operational excellence across Lyophilization processes, Control Room operations, and Batch Readiness execution—ensuring safe, compliant, and right-first-time production.

You will collaborate cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain to ensure inspection readiness, schedule adherence, and flawless batch execution while advancing continuous improvement initiatives that support our Mission to make the world healthier, cleaner, and safer.

A Day in the Life:

• Provide leadership and oversight for Lyophilization operations, ensuring validated process control, equipment performance, and regulatory compliance

• Oversee Control Room operations, including real-time monitoring, issue escalation, deviation management, and production decision support

• Own and drive Batch Readiness activities, ensuring materials, documentation, equipment, personnel, and systems are fully prepared prior to batch start

• Ensure manufacturing operations comply with cGMP, safety, quality systems, and regulatory requirements

• Lead, coach, and develop high-performing teams, fostering accountability, engagement, and continuous improvement

• Drive operational excellence initiatives focused on safety performance, cycle time reduction, yield improvement, and right-first-time execution

• Partner cross-functionally to resolve manufacturing issues, support investigations, implement CAPAs, and maintain inspection readiness

• Utilize performance data, metrics, and KPIs to monitor trends and implement sustainable improvements

• Manage operational budgets, staffing plans, and resource allocation to meet business objectives

• Support customer commitments by ensuring reliable, compliant, and on-time batch execution

Keys to Success:

Education

Advanced degree with 6+ years of experience, or Bachelor’s degree with 8+ years of experience in operations management within a regulated manufacturing environment (pharmaceutical or medical device preferred), or

In lieu of a degree, a minimum of 10 years of progressive experience in sterile manufacturing operations, including aseptic processing, Lyophilization, and critical systems monitoring

Preferred fields of study: Engineering, Chemistry, Pharmacy, Science, or related technical discipline

Experience

• Extensive experience in sterile/aseptic pharmaceutical manufacturing

• Strong knowledge of cGMP, aseptic manufacturing, quality systems, and regulatory requirements

• Experience with Lyophilization processes and batch control/manufacturing execution systems preferred

• Proven experience leading and developing operational teams

• Demonstrated success implementing operational excellence initiatives (Lean, Six Sigma)

• Experience managing inspections, regulatory interactions, and audit readiness

• Financial and budget management experience

Knowledge, Skills, Abilities

Knowledge

• In-depth understanding of aseptic processing, sterile manufacturing controls, and validated systems

• Knowledge of ERP systems, manufacturing execution systems (MES), and data-driven performance managemet

Skills

• Strong leadership and team development skills