R&D/Mfg Scientist II

Do you have a passion for innovative ideas and ground-breaking discoveries? With over $1 billion invested annually in R&D at Thermo Fisher Scientific, you’ll help overcome some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement take on cases through forensics. We empower our employees to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information

Florence, SC / Drug Substance

How will you make an impact?

Test raw materials, samples, stability, and production intermediates. Test active pharmaceutical ingredients as well. Develop and qualify methods. Ensure products meet quality standards. Collaborate with internal teams. Provide results to teams and clients.

What you will do:

• Perform routine and non-routine chemical tests and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples using internally developed and compendial test methods.
• Complete developmental and validated test methods using various analytical techniques such as HPLC, GC, spectroscopy, GC/MS, LC/MS, and traditional wet chemical testing. Train colleagues on these techniques. Provide thoughtful technical review of data collected by other employees.
• Recognize and report/investigate out-of-specification or unexpected results and non-routine analytical and product problems.
• Craft documentation of the testing/analysis and record the acquired results to sufficiently communicate the work's outcomes. Ensure compliance with prescribed lab procedures and systems when reporting the analysis results.
• Assist in writing/reviewing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites. Write and review Analytical Methods, validation protocols, validation reports, and SOPs as needed.
• Problem solving related to the processing of chemical procedures.
• Perform daily instrument calibrations / verifications as required and weekly/monthly inspection of safety equipment.

How you will get here:

Education

Bachelor’s degree in chemistry or a related field

Experience/Qualifications

• 5+ years of working experience in a laboratory preferred, (GLP or GMP/cGMP environment preferred) with analytical instrumentation, such as HPLC, GC, spectroscopy, GC/MS, LC/MS.
• Extensive knowledge and understanding of chemistry and analytical instrumental technologies as well as knowledge of qualitative and quantitative chemical analysis.
• Extensive knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Understanding of medical terminology, clinical data, and Good Manufacturing Practices (GMP).

Skills & Abilities

• Problem solving skills and logical approach to resolve scientific problems.
• Good interpersonal, communication (both oral and written), and presentation skills.
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Ability to write standard operating procedures, simple protocols, and reports.
• Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
• Ability to work on multiple projects simultaneously.

This position has not been approved for relocation assistance.

We strive to empower our clients to supply a healthier, cleaner, and safer world. Listen to our colleagues as they share 5 reasons why you should join our company. As a team of 100,000+ colleagues, we are united by values such as integrity, intensity, innovation, and involvement. Working together, we accelerate research, overcome scientific challenges, champion innovation, and provide support to patients. Begin your experience at our company, where we value diverse experiences and perspectives.

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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