QC Bioanalytical Associate I Position Available In Norfolk, Massachusetts

QC Bioanalytical Associate I
Location Plainville, Massachusetts, United States of America Job Id

R-01320575

Job Type Full time Category Quality & Regulatory Remote Fully Onsite
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 methods
Performs inventory and stocking of QC lab
Reviews data and enter results into LIMS system
Coordinates sample shipment to external labs
Performs routine laboratory preventative maintenance and cleaning
Revises technical documents (SOPs, Work Instructions)
Required Skills
Bachelor’s degree in biological sciences and minimum of 0-3 years of industry experience
Ability to manage timelines and meet internal/external deadlines
Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals
Experience 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 areas
Position requires frequent standing, bending, stopping, and the ability to lift 40 lbs
Ability to work with strong chemical odors such as Spor-Klenz and bleach
Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
Occasional 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.