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Analytical Development, Product Life Cycle
2 weeks ago
About Apotex Inc.
Job Summary
Responsible for managing the staff and activities of AD-PLCM Lab. Organizes, coordinates and oversees the product development process in a team based environment, provides guidance to scientists/chemists, implements team-oriented approach for the early stages to project completion. Evaluates technical data and decides on the course of action during PLCM process. Responsible for the quality of the newly developed analytical methods as well as their validation to support the regulatory submission of new API source.
Ensures continual review of SOPs and documentation to meet current regulatory requirements. Establishes close working relationships with R&D and Commercial units to create an integrated research environment and to ensure timely completion of new API sources as related submission documents for RA. Lends expertise to other areas within the Apotex organization. Assists Director in strategic planning, budgeting and staffing.
Job Responsibilities
Responsible for the quality of documentation and test results generated in the AD-PLCM
Establishes priorities and sets deadlines to meet overall PLCM project plan
Assigns projects to the staff, co-ordinates work, evaluates results and provides direction for course of action
Monitors the quality and productivity of the lab output to ensure that optimum levels are achieved. Makes recommendations to the Director for continuous improvement of lab operations
Identifies training needs for the staff. Initiates action to ensure that all training needs are met
Identifies training needs for the staff. Initiates action to ensure that all training needs are met
Responsible for the performance management of the staff. Makes recommendations for promotions, as justified, to the Director
Works as a member of a team to achieve all outcomes
Demonstrates corporate values in the performance of the work and interactions with others
Works closely with other units of Analytical Operations, provides expert advice to other members of the AO team
Investigates, encourages and uses unconventional/unique problem solving techniques to perform trouble-shooting on highly complex issues with respect to the stability of drug substances and drug products, chromatographic methodology etc
Oversees the resolution of more complex issues related to the project
All other duties as assigned.
Job Requirements
Bachelors in a scientific discipline especially Organic Chemistry or Analytic Chemistry or pharmaceutical sciences. Masters or Ph.D. preferred.
10 years of pharmaceutical industry experience with demonstrated achievements in the pharmaceutical industry.
Advanced knowledge of analytical, organic and solid-state chemistry, pharmaceutical solid dosage forms.
Demonstrated technical proficiency, scientific creativity, teamwork, and independent thought.
In depth knowledge of regulatory guidelines GMP and GDP.
Excellent written and verbal communication skills.
Leadership and supervisory skills demonstrated in previous management roles.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
