Supervisor, Qc Jobs

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.

This position will be site based in Cambridge, MA and will support our Viral Vector Services (VVS Cambridge) business unit of Thermo Fisher Scientific. At VVS Cambridge, 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.

The Supervisor will oversee the team performing routine testing for the manufacturing process, critical utility testing, and assay qualifications. This testing will include the qualification and evaluation of qPCR assays, infectivity assays including TCID50, and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by VVS.These assays must be performed according to written procedures and in compliance with cGMP regulations.

The incumbent will act as a leader in the lab helping management to hire and train new employees, schedule testing, troubleshoot assays and equipment, and act as a SME during internal and external audits.

• Oversee and schedule staff of Quality Control analysts.
• Troubleshoots assay and equipment failures with analysts.
• Interacts with clients for assay qualifications and onboarding activities.
• Provides training to junior level employees.
• Authors and execute investigations and change controls.
• Participates in recruiting and onboarding of new analysts.
• Onboards new equipment with a cross functional team (procurement, validation).
• Authors technical documents (SOPs, Work Instructions, Gap Analyses).
• Leads team huddle and MDI meetings.
• Act as a QC Bioanalytical SME during internal/external audits, risk assessments, and investigations.
• Oversee performance routine bioanalytical assays and method suitability testing.
• Coordinates analyst/assay scheduling.

Keys to Success:

• Bachelor’s Degree in biological science or related field required.

• Experience leading/supervising a team is highly preferred.
• 4 years of GXP or relevant regulatory experience with BS, or 2 years of relevant GXP experience with a Masters, or higher degree.

• 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 work 4 (10hr) days a week. Reporting Wed -Sat, 1st shift.
• Strong attention to detail.
• Good autonomous problem-solving skills.
• Strong communication skills (verbal and written).

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!

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