Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.


Job Summary

Under guidance of Scientific leader, Analytical product life cycle management, responsible for performing all activities in evaluation of new alternate API sources, investigations related to commercial methods, laboratory support work for Technical operation and compendia method evaluations for any commercial products. This group also responsible for, analytical method development and validation for new API source and methods that are related to commercial specifications, comprehensive testing of API and finished dosages, and generates regulatory submission documentation.  Acts as a key member in the project working team.

Job Responsibilities
  • Under guidance of senior chemist, performs validation of analytical testing procedure for drug substance and drug product.
  • As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
  • Conducts other tests required for dosage submissions.
  • Documents and reports results as per established SOP’s.
  • Provides technical support to other department for the responses to requirements of regulatory agencies.
  • Refers more contentious issues, with recommendations, to Scientific Leader
  • Work as a member of a team to achieve all outcomes.
  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements.
  • 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, pharmaceutical sciences, or related field.
  • BSc with 1 years or MSc with 0 years or PhD with 0 year experience in a pharmaceutical lab in an R&D environment.
  • Knowledge of HPLC method validation.
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software.
  • Knowledge of automated data acquisition systems is an asset.
  • Working knowledge of GC is an asset.
  • Good written and verbal English communication skills.



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.


from Apotex – Research & Development https://ift.tt/2SWQGj6

About Apotex

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.

Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.