Manager, Manufacturing Control & Readiness

Work Schedule

Environmental 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 this critical leadership role you will drive operational excellence across Lyophilization processes Control Room operations and Batch Readiness executionensuring 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 Bachelors 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

• 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

Abilities

• 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

Physical Requirements / Work Environment

• Ability to work in classified cleanroom environments

• Use of appropriate PPE required

Excellent Benefits

Benefits & Total Rewards Thermo Fisher Scientific

• Medical Dental & Vision benefits effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

• Annual Incentive Plan Bonus

Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

No relocation assistance 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

Equivalent combinations of education training and meaningful work experience may be considered.