QC Bioanalytical Associate I

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Location: Plainville, MA

Schedule/Hours: M-F 8-4:430 * Shift will transition to W-Sun or Sun-W Day Shift

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.

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 biopharmaceuticals, 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, training, and keeping up cGMP compliance practice to support group needs.

What you will do…

• Routine critical utility and product testing after successful training (TOC, pH/conductivity, Appearance, Osmolarity, qPCR, etc.).
• Review data to ensure data integrity and compliance.
• Participate in analytical method transfer and qualification.
• Assist in lab maintenance activities.
• Complete work following all applicable SOP’s and site procedures.

How you will get here…

Education

• Bachelor’s degree in biological sciences or related majors

Experience

• 0 + years of GMP experience required
• A combination of education and experience may be considered

Knowledge, Skills, Abilities

• 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
• Must be fluent in English

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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