About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Perform R&D and Commercial release tests in compliance with GMP and data integrity requirements. Responsible for develop and validate methods for analyzing pharmaceutical active and inactive ingredients using a wide variety of instruments. Interprets analytical data and generate complex scientific reports. In charge of deficiency response. Perform literature search, project evaluation, establish specification and lead new product development projects.
Job Responsibilities
- As a project leader, be responsible for NPD projects and lead junior chemists in product development. Establish physical properties related specifications.
- Evaluate and establish deficiency letter response strategies, conducting testing and draft deficiency response report.
- Develop, validate and technology transfer testing methods for R&D and commercial release. Issue method development summary, validation and technology transfer protocols and method validation and technology transfer reports.
- Establish and develop testing strategy by using state-of-the-art Physical Properties laboratory instruments for pharmaceutical drug substances and products. Develop and support other Apotex labs special investigation requests with various analytical techniques as required.
- Provides expert advice on the decision making of polymorphic forms, material particle size, and other physical properties information to management in new product development, submission, Product Life Cycle Management (PLCM) and patent related issues.
- Develop and implements strategies and work plans in the crystalline form preparation, identification and characterization by using various techniques of Powder x-ray diffraction, Thermal analysis (TGA/DSC), Microscope, Particle size analysis, laser particle size and DLS (Dynamic Light Scattering), FT-IR, Microscope FT-IR, FT-IR/NIR image system, ATR, Surface/material characterization (Nitrogen BET surface area and dynamic vapor adsorption), Inductively Coupled Plasma (ICP) ICP-OES and ICP-MS and the use of general analytical instruments.
- Instruct and train staff on the use of new instrumentation. Prepares SOP/WI on operation of new instruments.
- Evaluates current analytical procedures and recommends systems and/or modifications to increase laboratory efficiency. Evaluates analytical instrumentation and software and provides expert opinion on their quality and applicability to Apotex requirements.
- Maintains strong relationships with external providers/vendors and customers.
- Provides technical expertise and consultation to other Apotex laboratories.
- Identifies root causes of challenge projects. Investigates and recommends the usage of new or unconventional problem solving techniques to the next level. Establishes performance criteria for new and existing analytical instrumentation/systems.
- Keeps updated with new analytical techniques through literature, seminars, workshops etc.
- Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.
Job Requirements
- Recognized post secondary education in analytical chemistry, organic chemistry, material chemistry, material engineering, pharmaceutical sciences, or related field.
- BSc with 7 years or MSc with 5 years or PhD with 3 years’ experience in a pharmaceutical lab in an R&D environment with focus on physical property testing.
- Advanced knowledge of analytical and physical chemistry, pharmaceutical solid dosage forms.
- Preferred to have knowledge and experience in peptides.
- Demonstrated technical proficiency, scientific creativity, teamwork, and independent thought.
- Excellent written and verbal communication skills.
At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer 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.
The hiring range for this position is $73,008 - $121,680 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience. We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications. The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.
Apotex will use artificial intelligence to screen, select and/or assess your application for this job.
This job posting is for a role that is currently available and vacant at Apotex.
