Scientist II Jr Scientific Technical Writer

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

** Environmental Conditions*
* Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

** Job Description*
* ** Division/Site Specific Information:*
* Our Mississauga facility covers all phases of drug product development from early-phase formulation development to clinical trial material ( commercial supply ( the same plant using scalable equipment for non-GMP and GMP work.

** Discover Impactful Work:*
* Assist with preparation of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory ensuring they meet current regulatory, corporate and industry standards.
Perform bench work to support client projects.

** Shift schedule:*
* Monday u2013 Friday 9 AM u2013 5:30 PM

** Day in the Life:*
* Independently carryout LC/MS, HPLC, dissolution and physical testing analysis following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
Assist with preparation of technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
Demonstrated capability of independently performing Method Validation and Method Evaluation
Help toprovide input on generation ofmethod transfer plans for incoming projects.
Document all experimental datain accordance with Attributable, Legible, Contemporaneous,Original and Accurate (ALCOA).
Work Proficiency with Empower,NuGenesis, MS Word & Excel Software.
Recognize and report unexpected or Out Of Specification  (OOS) resultsimmediatelyto 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)

** Keys to Success:*
* *
* Education:

*
* B.Sc. in Chemistry required with 3-4 years performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations OR Masteru
2019s in Chemistry preferred with 2 years experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations
Experience in laboratory testing and method validation
Experience in writing method development protocols and reports is an asset

** Experience in LC/MS analysis in GMP*
* environment is an asset

** Equivalency*
* _:_
Equivalent combinations of education, training, and relevant work experience may be considered

** Knowledge, Skills*
* **,*
* ** and Abilities:*
* Strong knowledge of analytical method validation requirements. Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Knowledge of regulatory requirements including USP/NF and Ph. Eur. Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint). Experience in Empower software. Experience & knowledge of

** Analyst*
* and

** Chromeleon*
* software are added advantages. Well organized and detail oriented.
Excellent interpersonal and communication skills (both oral and written).
Ability to work well independently and in a team environment with limited supervision.
Ability to prioritize multiple tasks.
Proficient with the English language.

** Standards and Expectations:u202fu202f
** u202f
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.u202f Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems,u202fetc.).

Be client and patient consciousu
202fat all times. Understand Key Performance Indicators (KPI''s) 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.u202f

Consistently strives to improve skills and knowledge in related field. f

*
* Physical Requirements:

*
* Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/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 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…