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.

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

• 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