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 analystsMonitor performance of all routine and non-routine assaysAuthor and complete investigations, change controls, CAPAsAuthors technical documents (SOPs, Work Instructions, Gap Analyses)Provides training to junior level employeesCoordinates analyst/assay schedulingLeads team huddle and MDI meetingsParticipates in recruiting and onboarding of new analystsTroubleshoots assay and equipment failures with analystsBe a QC Microbiology SME during internal/external audits, risk assessments, and investigationsInteract with clients for assay qualifications and onboarding activities, as well as method suitability for bioburden and endotoxin testingMust 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 SkillsBachelor's Degree in biological science or related field required, with a minimum of 5 years of GXP or relevant experienceOR Higher Degree in biological science or related field required, with a minimum of 2 years of relevant GXP experienceAbility to handle timelines and meet internal/external commitmentsStrong interpersonal skills and ability to work cross functionally with a diverse group of individualsPreferred SkillsExperience 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 ScientificMedical, Dental, & Vision benefits-effective Day 1Paid Time Off & Designated Paid HolidaysRetirement Savings PlanTuition Reimbursement

OTHER

Relocation assistance is NOT providedMust 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