Scientist II Jr Scientific Technical Writer Full-time NEW

Job Title

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 – Friday 9 AM – 5:30 PM

Day in the Life

• 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.
• Demonstrated capability of independently performing Method Validation and Method Evaluation
• Help to 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).
• Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• 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)

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 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
• 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:

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 (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.

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 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.

Excellent Benefits

• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement

Compensation:

The estimated annualized pay range for this position in Ontario is $50,800.00–$76,150.00.