QC Scientist III

Job Description

When you are part of the team at Thermo Fisher Scientific, you'll do important work.
And you'll have the opportunity for continual growth and learning in a culture that empowers your development.
With annual revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make meaningful contributions to the world.

Location/Division Specific Information
Work Location: St. Louis, MO (on-site)

Group: Pharma Services Group

This position supports the QC Biochemistry team for our Biologics Division in St. Louis, MO.

How will you make an impact?

As part of the Quality Control Biochemistry Group, you directly impact patients' lives by providing testing to ensure their biologic pharmaceuticals are safe and potent.

What will you do?

• Conduct routine compendial, purity, and impurity testing of pharmaceutical release, stability, and in-process samples by internally developed, qualified, and validated test methods.
• Verifies and processes analytical data.
  Facilitates development of quality products through participation and representation on group and department level project teams.
• Leads the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, and identity, utilizing gel electrophoresis, residual DNA, spectroscopy, and traditional wet chemical testing.
• Supports qualification of test methods for pharmaceutical concentration, purity, and impurity testing.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
• Performs instrument calibrations / verifications as required.
• Communicates, clearly and accurately, the results of work by creating cGMP documentation of the testing/analysis and obtained results.
  Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Leads, prepares, and files regulatory documents in support of internal projects.
  Provides communications with outside departments, corporate sites, agencies, and clients.
• Coordinates and leads writing of SOPs, policy manuals, and other instructional documents.
• Maintains a neat and organized work area, instrumentation, and testing materials.
• Writes investigation records in TrackWise system.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains the necessary compliance status required by company and facility standards.

How will you get here?

Education

• Associates Degree with 7 or more years of relevant work experience or a Bachelor's degree with 5 or more years of relevant work experience, STEM degree preferred

Experience

• 5 years of experience in the biopharmaceutical or pharmaceutical industry.
• Extensive knowledge/use of Micro-Pipetting
• Experience in performing Protein Concentration and Capillary Gel Electrophoresis experiments is strongly preferred.
• Working knowledge of scientific principles for wide range of analytical techniques strongly recommended.
• Equivalent combinations of education and relevant work experience may be considered.

Knowledge, Skills and Abilities

• Excellent knowledge and understanding of chemistry and analytical instrumental technologies
• Good knowledge of qualitative and quantitative chemical or microbiological analysis.
• Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
• Good problem-solving skills and logical approach to solving scientific problems.
• Excellent proficiency with Capillary Gel Electrophoresis, Capillary Isoelectric Focusing Residual DNA, Protein Concentration, and compendia techniques.
  Experienced in method development and validation principles.
• Good presentation skills to present information to customers, clients, and other employees.
• Routine use of Microsoft Office Suite
• Ability to read, analyze, and interpret technical procedures and governmental regulations.

This position has not been approved for relocation assistance.

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.
As 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.

Apply today!
http://jobs.thermofisher.com

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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