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QC Microbiology Lead

Thermo Fisher Scientific
Plainville, Massachusetts, US
Closing date
Sep 4, 2021

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QC Microbiology Team Lead
Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
Plainville, MA
How will you make an impact?
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 be to assist in implementing the routine monitoring of the environment, critical utilities, and the performance of microbiological assays. 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.
What will you do?
The Team Lead will use their depth of experience in the QC Microbiology labs to drive the implementation of a brand-new testing laboratory. As part of this endeavor, the following areas will be the key areas of focus:
- Implementation of routine microbiology assays and method suitability testing
- Authors final reports for assay qualifications
- Determine the appropriate SOP's and processes required
- Authors technical documents (SOPs, Work Instructions, Gap Analyses)
- Authors and execute investigations and change controls
- Provides training to junior level employees
- Coordinates analyst/assay scheduling
- Works closely with QC Management to develop analyst training plan
- Leads morning huddles and afternoon MDI meetings
- Participates in recruiting and onboarding of new analysts
- Troubleshoots assay and equipment failures with analysts
- Act as a QC Micro SME during internal/external audits, risk assessments, 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 action notices or shutdowns
Required Skills
- Bachelor's degree in biological sciences and minimum of 5 years of industry experience
- Ability to manage timelines and meet internal/external deadlines
- Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals
Preferred Skills
- Master's degree and minimum of 3 years of industry experience
Special Requirements
- Ability to gown and gain access to cleanroom areas
- Position requires frequent standing, bending, stopping, and the ability to lift 40 lbs
- Ability to work with strong chemical odors such as Spor-Klenz and bleach
- Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
- Occasional off shift or weekend hours may be required to meet business needs
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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