QC Bioanalytical Associate I
QC Bioanalytical Associate I
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 materialsJob Description
Thermo Fisher Scientifics 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
- Bachelors 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
- Masters 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.
Required Experience:
IC
Employment Type
Full-Time
