Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

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?

The key focuses will be to assist in the timely testing of in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, 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.

What will you do?

The Team Lead will use their depth of experience in the QC Bioanalytical 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:

Routine Molecular, Viral, Cell and Tissue Culture testing using qPCR, ddPCR, and other analytical methodsPerforms inventory and stocking of QC labReviews data and enter results into LIMS systemCoordinates sample shipment to external labsPerforms routine laboratory preventative maintenance and cleaningRevises technical documents (SOPs, Work Instructions)

Required Skills

Bachelor’s degree in biological sciences and minimum of 0-3 years of industry experienceAbility to manage timelines and meet internal/external deadlinesStrong interpersonal skills and ability to work cross functionally with a diverse group of individualsExperience with qPCR, ddPCR, and other analytical methods

Preferred Skills

Master’s degree and minimum of 1 years of industry experience

Special Requirements

Ability to gown and gain access to cleanroom areasPosition requires frequent standing, bending, stopping, and the ability to lift 40 lbsAbility to work with strong chemical odors such as Spor-Klenz and bleachPosition is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situationsOccasional 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.