Manager, Manufacturing Control & Readiness

Thermo Fisher Scientific•Greenville, NC

About The Position

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.

Requirements

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
Extensive experience in sterile/aseptic pharmaceutical manufacturing
Strong knowledge of cGMP, aseptic manufacturing, quality systems, and regulatory requirements
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
Strong leadership and team development skills
Excellent project management and organizational capabilities
Advanced problem-solving and decision-making skills
Effective communication and stakeholder engagement skills across all organizational levels
Proficiency in Microsoft Office Suite applications
Ability to drive cultural change and foster continuous improvement
Ability to make timely, data-driven operational decisions
Ability to work in cleanroom/controlled environments and use required PPE when needed
Ability to manage multiple priorities in a fast-paced manufacturing environment
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

Nice To Haves

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

Responsibilities

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