Thermo Fisher Scientific Scientist I (QC-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
St. Louis, MO
How will you make an impact?
Provides moderately complex analyses in a chemistry or microbiological environment within 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, CEX, 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. May interact with clients.
Prepare and assist in filing regulatory documents in support of internal projects. Provide communications with outside departments, corporate sites, agencies, and clients.
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 communications 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.
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. 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 .
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.