Scientist II, Analytical R&D

Job Description

The Scientist II will conduct laboratory work as necessary to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner. Use judgment in making adaptation and modifications on all assignments. Provide routine and non-routine analyses in an analytical chemistry laboratory following standard practices. Perform analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and active pharmaceutical ingredients, including method development and qualification activities. Support internal development and/or manufacturing operations. Make detailed observations and reviews, document, and communicate test results internally and externally to clients.

Key Responsibilities:

• Consistently align with housekeeping standards.
• Maintain a clean and safe work environment including work area, instrumentation, and testing materials.
• Understand and work in compliance with all cGMP, OSHA, and safety regulations, BOPs and SOPs.
• Perform cGMP procedures, lab procedures, BOPs and SOPs.
• Perform daily instrument calibrations / verifications as required.
• Responsible for weekly/monthly inspection of safety equipment.
• Assemble and operate laboratory (bench scale) equipment and carries out experiments independently.
• Conduct routine and non-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.
• Perform developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trains other employees 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. 
• Clearly and accurately communicate the results of work by documenting the testing/analysis and obtained results. Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Assist in preparing 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 if needed.
• Solve problems related to the processing of chemical procedures.
• Ability to drive functional, technical and operational excellence.  Ability to inspire and drive team effectiveness.

Education:

• Bachelor’s degree in chemistry or related field required; equivalent combinations of education, training, and relevant work experience may be considered.

Experience:

• 5+ years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)
• 5+ years of experience working with analytical instrumentation, such as HPLC, GC, CE, ICP, LC/MS and dissolution apparatus preferred

Competencies: 

• Knowledge and understanding of chemistry and analytical instrumental technologies.
• Knowledge of qualitative and quantitative chemical analysis.
• Knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, descriptive organic chemistry, and clinical data.
• Good problem solving skills and logical approach to solving scientific problems.
• Good interpersonal and communication skills (both oral and written). Good presentation skills to present information and respond to inquiries to customers, clients, regulatory agencies and colleagues.
•  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.

Physical Requirements

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer

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.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)