Supervisor, QC Microbiology
Thermo Fisher Scientific

Job Description

As part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work:

As this is a brand-new site currently in construction, the lead will be integral with ensuring operational readiness of the lab to support GMP production. The key focuses will he to assist in the timely qualification of the new facilities classified areas, critical utilities, in-process and release testing of toxicological, clinical, and commercial grade bin-pharmaceuticals, qualification/validation of analytical methods for support of vector cGMP compliant Manufacturing and the transfer aml validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC Lesting. The incumbent will act as a leader in the lab helping management to interview and train new employees, schedule testing, troubleshoot assays and equipment, and act as a SME on the path to operational readiness.

This position is for First Shift, from Sunday to Wednesday(4x10 hour).

A Day in the Life:

The Supervisor will use their depth of experience in the QC Microbiology labs Lo drive the implementation of a new testing laboratory. As part of this endeavor, the following areas will be the key areas of focus:

• Implementation of routine testing for microbiological assays, bioburden, endotoxin, environmental monitoring.
• Determine the appropriate SOP's and processes required.
• Authors technical documents (SOPs, Work Instructions, Gap Analyses).
• Authors and execute investigations and change controls.
• Assist in building a trained competent team of QC analyst to support GMP testing.
• Provide• training to junior level employee.
• Coordinates analyst/assay scheduling.
• Works closely with QC Management to develop analyst training plan.
• Lead morning huddles and afternoon MDI meetings.
• Participates in recruiting and onboarding of new analysts.
• Troubleshoots assay and equipment failures with analysis.
• Act as a QC SIE during internal/external audits, risk assessment; and investigations.
• Interacts with clients for technical transfer and onboarding activities.
• Onboard new equipment with a cross functional team (procurement, validation).
• Coordinates QC return to service activities for notices or shutdowns.

Keys to Success:

Education/Experience

• Bachelor's degree in science; preferably Microbiology or Biology, or related field with a minimum of 5 years of industry experience, or regulated environment, or master's degree and minimum of 3 years of industry experience, or regulated environment.
• Experience with endotoxin, bioburden, environmental monitoring, and other analytical methods preferred.
• Experience performing environmental monitoring, critical utility sampling and microbiological assay is a plus.

Knowledge, Skills, Abilities

• Ability to manage timelines and meet internal/external deadlines.
• Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals.
• Ability to gown and gain access to cleanroom areas.
• Position requires frequent standing, bending, stopping, and the ability to lift 50 lbs.
• Ability to work with strong chemical odors.
• Position is considered essential personnel and may be required to work during inclement weather or other internal/external emergency situations.
• Occasional off shift or weekend hours may be required to meet business needs.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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