QC Scientist II at Thermo Fisher Scientific in St. Louis, Missouri

Job Description:

Work Schedule

First Shift (Days)



Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description



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



Based in St Louis, MO and support the Drug Substance Division at Thermo Fisher Scientific.




Discover Impactful Work:



At Thermo Fisher Scientific Inc., your work will be exceptionally impactful. As a QC Scientist II, you'll be part of an ambitious team dedicated to flawless execution. You'll support GMP manufacturing, from early to late-stage clinical and commercial efforts, and contribute to stability testing and other client-requested endeavors.




A Day in the Life

• Perform HPLC/UPLC testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects.
  
  


• Participate in analytical method validation/transfer, method establishment/qualification routine, and stability analysis.
  
  


• Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods (i.e., Reverse Phase, SEC, Titer concentration, CEX, etc.).
  
  


• Compile data for documentation of test procedures, prepare reports, and ensure all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
  
  


• Assist in the development of new concepts, techniques, and standards, and prepare Certificates of Analysis (CoAs).
  
  


• Recognize and report out-of-specification/out-of-trend results to laboratory management, recommending solutions.
  
  


• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
  
  


• Engage in laboratory activities, including safety inspections and client audits.
  
  

Keys to Success




Education

• Bachelor's degree preferred or equivalent experience in chemical pharmaceutical, biology, chemistry, biotechnology, or related field in lieu of degree.
  
  


• High school diploma or equivalent required.
  
  

Experience

• 3 years of related experience in a regulated environment required.
  
  


• HPLC experience in pharma or a related relevant field required.
  
  

Knowledge, Skills, Abilities

• Flexibility and organization.
  
  


• Strong planning skills.
  
  


• Proven track record to work effectively in a team.
  
  


• Attention to detail.
  
  


• Positive demeanor.
  
  


• Knowledge of MS Office programs.
  
  


• In-depth knowledge of common analytical techniques and required instrumentation.
  
  


• Familiarity with laboratory computer programs (Empower, LIMs, TrackWise).
  
  

Benefits



We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides an innovative, forward-thinking work environment with outstanding career and development prospects. Join us and become part of an exciting company culture that stands for integrity, intensity, involvement, and innovation! Apply Now