Scientist I – Analytical Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

JOB DESCRIPTION

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Business Title: Scientist I – Analytical Operations

Effective Date: 28.OCT.2022

Revision #: 1

Version #: 2.0, CURRENT

Replaces: 21.MAY.2021

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

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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.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this

job. The description is not to be construed as a comprehensive statement of work, responsibilities, or

requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required

skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully

align with all obligations imposed by the legislation of each country in which it operates, including the

implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Scientist I – Analytical Operations Page 3 of 3

ACKNOWLEDGEMENT FOR RECEIPT OF JOB DESCRIPTION

Business Title: Scientist I - Analytical Operations Effective Date:

(DD.MMM.YYYY)

28.OCT.2022

Department: Lab Operations Version #: 2.0, CURRENT

I have received a copy of the job description indicated above and have read and understand its contents.

____________________________________________________________________________________________

Employee Name Employee Signature Date (DD.MMM.YYYY)

I have reviewed and approve the job description indicated above.

____________________________________________________________________________________________

Department Manager Name Department Manager Signature Date (DD.MMM.YYYY)

____________________________________________________________________________________________

Compensation

The estimated annualized pay range for this position in Ontario is $51,200.00–$70,000.00.