Scientist II - Analytical Operations

** Work Schedule*
* Standard (Mon-Fri)

** Environmental Conditions*
* Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

** Job Description*
* ** Division/Site Specific Information*
* 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.

** Shift

Schedule:

*
* During your first 3-4 months you will work day shift 9 AM - 5:30 PM, but our laboratories operate a day and afternoon shift and you may be required to work afternoons which right now is from 2:00 PM– 10:30 PM.

** Discover Impactful Work:*
* 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.

** Day in the Life:*
* 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)

** Keys to Success:*
* *
* Education and Experience:

*
* 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.
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 OR
Minimum 1 year demonstrated proficiency as a Scientist I
(internal applicants).

** 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.
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.

*
* Physical Requirements:

*
* Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation…