Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
The Scientist II, Formulations is responsible for manufacturing products for the Bulk Formulations team and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators and controls for IVD use. Participates in process improvement projects.
What will you do?

* Manufacture advanced reagents, calibrators, controls and buffers following cGMPS
* Perform in-process testing using clinical analyzers. Review and analyze data.
* Review other manufacturing operators/scientist2019s batch records.
* Maintain and analyzes lot histories for trends and discrepancies.
* Weigh, transfer, and mix required chemicals
* Perform product filtrations
* Train Scientist 1 and 2 on equipment/procedures/processes
* Participate in process improvement projects to improve efficiencies and support business needs.
* Initiate and complete DCO
* Initiate and support investigations for NCARS, CAPAs, and Variances
* Maintain and troubleshoot equipment as appropriate.
* Keep department supervisor and/or manager updated on all issues
* Perform other job duties as required.

How will you get here?

* BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 1-3 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted

Experience 200B

* Experience in working with potentially hazardous chemicals and human source materials
* Laboratory skills and knowledge of safety precautions
* IVD manufacturing experience

Knowledge, Skills, Abilities

* Laboratory skills and knowledge of safety precautions
* Familiarity with Quality System Regulations and ISO 13485 regulations
* Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
* Strong laboratory skills including pipetting, safety, and hazardous chemical handling
* Must be organized and detail oriented to be able to prioritize own and other2019s work and meet business productivity metrics
* Self-sufficient, self-motivated, and focused
* Must be able to lift 25 lbs routinely

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com