Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Summary:
Provide analytical support in the Laboratory Operations Department by following standard practices.
Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial
batches supporting development and/or manufacturing operations. Make detailed observations and review,
document, and communicate test results.
Essential Functions:
Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original
and Accurate (ALCOA).
Carry out independently HPLC, dissolution and physical testing analysis testing following established
procedures Analytical Methods & Standard Operating Procedures (SOPs).
Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
Perform basic troubleshooting to overcome system suitability failures.
Recognize and report 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)
REQUIRED QUALIFICATIONS
Education:
B.Sc. in chemistry or a related field.
Experience:
Experience with common laboratory equipment and operations.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Understanding of basic chemistry. 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.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team
members, modelling positive team principles and partnering to meet project and departmental objectives.
Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures
(SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.
Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual
management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key
Performance Indicators and strive to improve the performance of the team by identifying areas for system
improvements and engage in problem solving. Model positive thinking and is open to change, motivating
the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement
Scientist I – Analytical Operations Page 2 of 3
in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives
to improve skills and knowledge in related field.
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
(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.
Compensation
The estimated annualized pay range for this position in Ontario is $51,200.00–$70,000.00.
