Scientist I - Development Operations

at  Thermo Fisher Scientific

SUMMARY:

Provide analytical support in the Laboratory Operations Department by following standard practices. Assist with method development and evaluation activities. Perform method validations and Research & Development (R&D) analytical testing. Make detailed observations and review, document, and communicate test results.

EDUCATION:

B.Sc. in chemistry or a related field.

EXPERIENCE:

Previous experience in a science related environment.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES:

Good understanding of basic chemistry and experience with common laboratory equipment and operation. Good understanding of chromatographic separations. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Works well independently and in a team environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency in the English Language.

• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carry out HPLC, dissolution and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Work Proficiency with Empower, NuGenesis, LIMS, SM, MS Word & Excel Software.
• Perform basic troubleshooting to overcome system suitability failures.
• Follow method validation protocols and carry out method validation bench work.
• Support ECS (excipient compatibility study) testing.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conduct laboratory investigations under direction.
• Maintain a safe working environment, lab 5S and report potential hazards.
• Perform alternating or rotating shift work (as required)