Scientist II Jr Scientific Technical Writer

Thermo Fisher Scientific•Mississauga, ON

1d•CA$50,800 - CA$76,150•Onsite

About The Position

Our Mississauga facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in 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.

Requirements

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 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
Experience in laboratory testing and method validation
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.
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.
Follow all Environmental Health & Safety Policies and Procedures.
Must be legally authorized to work in Canada without sponsorship
Must be able to pass a comprehensive background check

Nice To Haves

Experience in writing method development protocols and reports is an asset
Experience in LC/MS analysis in GMP environment is an asset
Experience & knowledge of Analyst and Chromeleon software are added advantages.

Responsibilities

Independently carry out 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.
Independently performing Method Validation and Method Evaluation
Provide input on generation of method transfer plans for incoming projects.
Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
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)
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 (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.
Consistently strives to improve skills and knowledge in related field.