Scientist I, Research & Development

Thermo Fisher Scientific - Florence, SC

Full-time - Entry Level

Florence, SC

Computer and Electronic Product Manufacturing

About the position

The Scientist I will conduct laboratory work to assure that products are tested per operating procedures. This role is critical in ensuring that work is carried out in an efficient and safe manner, applying judgment in making adaptations and modifications on all assignments. The Scientist I will provide routine analyses in an analytical chemistry laboratory following standard practices and will perform analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and active pharmaceutical ingredients (APIs), including method development and qualification activities. This position supports internal development and/or manufacturing operations and requires making detailed observations, reviewing, documenting, and communicating test results effectively. Key responsibilities include maintaining a clean and safe work environment, understanding and complying with all current Good Manufacturing Practices (cGMP), OSHA, and safety regulations, and performing daily instrument calibrations and verifications as required. The Scientist I will be responsible for the weekly/monthly inspection of safety equipment and will assemble and operate laboratory equipment while carrying out experiments under the mentorship of a senior scientist. The role involves conducting routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples using both internally developed and compendial test methods. The Scientist I will also perform developmental and validated test methods using various analytical techniques such as HPLC, GC, spectroscopy, GC/MS, and LC/MS, and will recognize and report out-of-specification or unexpected results and non-routine analytical and product problems. The position requires clear and accurate communication of results through documentation of testing and analysis, as well as assisting in preparing regulatory documents and communications with external agencies and clients. Collaboration with other scientists to resolve problems related to chemical procedures is essential, along with the ability to drive functional, technical, and operational excellence. The Scientist I should possess good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP), as well as strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills are necessary, along with the ability to multi-task efficiently.

Responsibilities

• Consistently aligns with housekeeping standards.
• Maintains a clean and safe work environment including work area, instrumentation, and testing materials.
• Understands and works in compliance with all cGMP, OSHA, and safety regulations, and SOPs.
• Performs cGMP procedures, lab procedures, and SOPs.
• Performs daily instrument calibrations / verifications as required.
• Responsible for weekly/monthly inspection of safety equipment.
• Assembles and operates laboratory (bench scale) equipment and carries out experiments under mentorship of a scientist.
• Conducts routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples by internally developed and compendial test methods.
• Performs developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
• Clearly and accurately communicates the results of work by crafting documentation of the testing/analysis and acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assist in preparing regulatory documents and other communications with external agencies and clients.
• Gives information to writing of Analytical Methods, validation protocols, validation reports, and SOPs if needed.
• Collaborate with scientists to resolve problems related to the processing of chemical procedures.

Requirements

• Bachelor's degree in chemistry or related field required.
• 1+ years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)
• Experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus preferred.
• 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.
• Proficiency with HPLC, GC, LC/MS and Dissolution techniques.
• Good interpersonal and communication skills (both oral and written).
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Ability to write standard operating procedures, simple protocols, and reports.

Nice-to-haves

• New Graduates are considered! Academic experience considered.