Scientist II

Business Title: Scientist II – Development Operations 

Effective Date:

Revision #:1

Version #:, CURRENT R-01204008

Replaces:

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. 

Essential Functions:

Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).

Independently carry out HPLC, dissolution, GC and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).

Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.

Perform advanced troubleshooting to overcome system suitability failures.

Author technical documents such as analytical methods and prepares data summaries.

Follow method validation protocols and carry out method validation bench work.

Assistwith method evaluation and development work.

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 and report potential hazards.

Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

in chemistry or a related field.

Experience: 

Minimum of 2 years of experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations OR

Minimum of 1 year demonstrated proficiency as a Scientist I

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered. 

Knowledge, Skills and Abilities: 

Good understanding of basic chemistry. Advanced understanding of chromatographic separations. Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Good problem-solving skills and applies a logical approach to solving scientific problems. Good interpersonal and communication skills (both oral and written). Ability to read, analyze 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. Willingly assists junior chemists in problem solving and training. Works well independently and in a team environment.Proficiency with 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 SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Models 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 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: 

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.