• QC Micro Supervisor

    ThermoFisher Scientific (Plainville, MA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

    Job Description

    Job Description

    Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (COMO) 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 confirmed competencies and strong character to join our team and help lead our organization into the future.

     

    Location

     

    Plainville, MA

     

    Position is Monday- Friday 9:00AM- 5.30PM.

     

    How will you make an impact?

     

    The supervisor will be responsible for the team performing routine testing for the manufacturing process, critical utility testing, and assay qualifications! 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.

     

    + Manage the scheduling of staff Quality Control analysts

    + Monitor performance of all routine and non-routine assays

    + Author and complete investigations, change controls, CAPAs

    + Authors technical documents (SOPs, Work Instructions, Gap Analyses)

    + Provides training to junior level employees

    + Coordinates analyst/assay scheduling

    + Leads team huddle and MDI meetings

    + Participates in recruiting and onboarding of new analysts

    + Troubleshoots assay and equipment failures with analysts

    + Be a QC Microbiology SME during internal/external audits, risk assessments, and investigations

    + Interact with clients for assay qualifications and onboarding activities, as well as method suitability for bioburden and endotoxin testing

    + Must have the ability to troubleshoot assays, equipment, and assist with problem solving in the lab!

    + Onboard new equipment with a cross functional team (procurement, validation)

     

    How will you get there?

    Required Skills

    + Bachelor's Degree in biological science or related field required, with a minimum of 5 years of GXP or relevant experience

    + OR Higher Degree in biological science or related field required, with a minimum of 2 years of relevant GXP experience

    + Ability to handle timelines and meet internal/external commitments

    + Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals

    Preferred Skills

    + Experience leading/supervising a team is highly preferred

     

    At Thermo Fisher Scientific, each one of our 75,000 outstanding minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customer

    Excellent Benefits

    + Benefits & Total Rewards | Thermo Fisher Scientific (https://jobs.thermofisher.com/global/en/total-rewards)

    + Medical, Dental, & Vision benefits-effective Day 1

    + Paid Time Off & Designated Paid Holidays

    + Retirement Savings Plan

    + Tuition Reimbursement

    OTHER

    + Relocation assistance is NOT provided

    + Must be legally authorized to work in the United States now and in the future,

    + Must be able to pass a comprehensive background check, which includes a drug screening

     

    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.