Scientist I Development Operations
Job Description
Work Schedule
Flex Shifts 40 hrs/wkEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob Description
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:
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. Assist with method validation activities.
Shift schedule: During your first 3-4 months you will work day shift, but our laboratories operate a day and afternoon shift and you may be required to work afternoons which right now is 2:00 PM – 10:30 PM.
Day in the Life:
Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original
and Accurate (ALCOA).
Work Proficiency with Empower, NuGenesis, LIMS, SM, MS Word & Excel Software.
Perform basic troubleshooting to overcome physical testing failures.
Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor
and conduct laboratory investigations under direction.
Follow method validation protocols and carry out method validation bench work.
Carry out basic physical testing (such as powder characterization tests, Ultraviolet(UV), Fourier
Transform Infra red (FTIR), Karl Fisher, Microscopy, hardness, friability, disintegration, water activity,
sieve analysis).
Maintain a safe working environment, lab 5S and report potential hazards.
Perform alternating or rotating shift work (as required)
Keys to Success:
Education:
B.Sc. in Chemistry.
Experience:
Previous experience in a GMP environment is an asset.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Good understanding of basic chemistry and experience with common laboratory equipment and operation. Good 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.
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.
Excellent Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
OTHER
Relocation assistance is NOT provided
Must be legally authorized to work in Canada without sponsorship
Must be able to pass a comprehensive background check
Compensation
The estimated annualized pay range for this position in Ontario is $51,200.00–$76,850.00.