QC Microbiology Supervisor

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.

Location

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 the timely qualification of the new facilities’ classified areas, critical utilities, in-process and release testing of toxicological, clinical, and commercial grade bio-pharmaceuticals, qualification/validation of analytical methods for support of vector cGMP compliant Manufacturing and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing. 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 Wednesday to Saturday (4x10 hour).

What will you do?

The Supervisor 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 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 analysts to support GMP testing
• 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 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

• Minimum education requirement: Bachelor’s degree in biological sciences and minimum of 5 years of industry experience or Master’s degree and minimum of 3 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
• Experience with endotoxin, bioburden, environmental monitoring, and other analytical methods

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

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.