QC Bioanalytical Associate II
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 QC Bioanalytical Associate I will be an integral member of the group ensuring operational readiness of the lab followed by performing QC analytical testing to support GMP production. The key focuses will be to assist in the timely completion of in-process and release testing of clinical and commercial grade bio-pharmaceuticals, qualification/validation of analytical methods for support of viral vector cGMP manufacturing and the transfer and validation of methods from clients. The incumbent will act as an analyst by assisting in equipment setup, documentation, routine testing and training while practicing cGMP compliance to support group needs.
What will you do?
The Associate I will use their knowledge and experience to work in a brand-new QC bioanalytical testing laboratory. They will develop their career as the lab grows. As part of this endeavor, the following areas will be the key areas of focus:
- Complete requisite document and in-lab training. cGMP and related documents training as well as training in the lab.
- Routine critical utility and product testing after successful training (pH. osmolality, TOC, conductivity, etc.).
- Review data to ensure data integrity and compliance.
- Participate in testing required as part of analytical method transfer and qualification.
- Assist in lab maintenance activities.
- Complete work following all applicable SOP’s and site procedures.
Required Skills
- Bachelor’s degree in biological sciences or related majors - 0-2 years of GMP experience
- Strong interpersonal skills
Preferred Skills
- Master’s degree
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
- Ability to work 10 hour shift which includes one weekend day
- 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.