Scientist II - Analytical Operations

Thermo Fisher Scientific•Mississauga, ON

4d•CA$62,000 - CA$93,050•Onsite

About The Position

Thermo Fisher Scientific offers industry-leading pharma services through our Patheon™ brand, providing an integrated global network of scientific, technical, regulatory, and quality experts committed to helping deliver medicines to patients faster. The Mississauga site supports all phases of drug product development — from early-phase formulation development to clinical trial material to commercial supply — within the same facility using scalable equipment. The site supports non-GMP and GMP work for highly potent and low-potent compounds, complex formulations, pediatric dosage forms, patent-extension strategies, and conventional oral solid dosage forms. This role provides analytical support in the Laboratory Operations Department by following standard practices. Performs analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations. Makes detailed observations and review, document, and communicate test results. Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Independently carries out HPLC, dissolution, GC, and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs). Works Proficiency with Empower, NuGenesis, MS Word & Excel Software. Performs advanced troubleshooting to overcome system suitability failures. Prepares data summaries and interprets results. Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction. Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required).

Requirements

Minimum B.Sc. in Chemistry required with 3-4 years experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations.
Good understanding of basic chemistry and experience with common laboratory equipment and operation.
Advanced 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.
Must be legally authorized to work in Canada
Must be able to pass a comprehensive background check

Nice To Haves

Master’s in Chemistry preferred with 2 years experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations
Proficiency with Empower, NuGenesis, MS Word & Excel Software.

Responsibilities

Provides analytical support in the Laboratory Operations Department by following standard practices.
Performs analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations.
Makes detailed observations and review, document, and communicate test results.
Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
Independently carries out HPLC, dissolution, GC, and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
Performs advanced troubleshooting to overcome system suitability failures.
Prepares data summaries and interprets results.
Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction.
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required)