Thermo Fisher Scientific Scientist 1 (HPLC) in Saint Louis, Missouri
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.
How will you make an impact?
Provides moderately complex analyses in a chemistry or microbiological environment with defined procedures and practices. Performs analytical methods for moderately complex testing on a variety of in process, stability, and release samples. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.
What will you do?
Conduct testing of materials and products using a variety of equipment and test methods (Reverse Phase, SEC, Titer concentration, Cation Exchange, etc.)
Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems, recommends solutions.
Perform method validation and/or qualification testing as needed.
Maintain and troubleshoot analytical instrumentation as needed. Clean and organize work space.
Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results. Record and report results of analysis in accordance with prescribed lab procedures and systems.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.
Author SOP's, test methods, forms, and other documents in the electronic document management system (eDMS). Review and revise test methods and other lab documents as necessary. Review departmental documentation (e.g., Standard Operating Procudures, TMs, and forms).
Interact with auditors/clients during visits and tours as needed.
Communicate with outside departments, corporate sites, and regulatory agencies as needed.
Other job duties as assigned.
How will you get here?
- Bachelor's degree in physical science, preferably in Chemistry, Biochemistry, or Biology.
Minimum of 1 year of HPLC experience in the pharmaceutical industry.
Experience with advanced LC assays is a plus (Titer, SEC, CEX, etc.)
Working knowledge of Empower is a plus.
Extensive knowledge of GMP regulations in cGMP manufacturing environment
Working knowledge of scientific principles for wide range of analytical techniques strongly preferred.
Knowledge, Skills, Abilities
Good knowledge and understanding of chemistry and analytical instrumental technologies.
Good knowledge of qualitative and quantitative chemical or microbiological analysis.
Good knowledge 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.
Strong interpersonal and communication skills, written and oral.
Routine use of MS Excel, MS PowerPoint, MS Access, and MS Word is essential.
Ability to read, analyze, and interpret technical procedures and governmental regulations.
Ability to write standard operating procedures, simple protocols, and reports.
Ability to respond to common inquiries or complaints from customers or regulatory agencies.
Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
Ability to drive functional, technical and operational excellence.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.