About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Under minimum guidance of Scientist, Analytical Development, responsible for performing all activities in early development research, analytical method development and validation for new products, comprehensive testing of API and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.
- Prepares working plan for new projects and provides timeline to the project working team.
- Develops stability indicative analytical methods for drug substance and drug product as well as the procedures used to determine the residue on manufacturing equipment.
- Prepares draft methods and method validation protocols.
- Performs validation of analytical testing procedure for drug substance and drug product including dissolution methods.
- Evaluates the stability and determines physicochemical properties of the drug substance.
- Evaluates the stability performance of the trial formulations under forced degradation conditions with comparison of the reference product.
- Performs isolation and purification of degradation products.
- Prepares stability reports for forced degradation, proposes degradation pathway and provides recommended storage condition for drug products.
- Provides justification for specification limit of degradation products based on ICH guideline, stability data and compendia requirements.
- Performs releasing tests for bio batches and initial tests for stability batches. Conducts other tests required for dosage submissions.
- Documents and reports results as per established SOP’s.
- Provides technical support to other department for the issues related to the stability of drug substance and drug product or for the responses to requirements of regulatory agencies.
- Work as a member of a team to achieve all outcomes.
- Demonstrates corporate values in the performance of the work and interactions with others.
- Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.
Technology/Instrumentation (type & complexity)
- Wet chemistry and analytical bench techniques.
- HPLC, GC, spectrophotometer, dissolution apparatus and physical testing instruments.
- Chromatographic software and LIMS.
Experimental or Methodological Design (if applicable)
- Chromatographic method development and validation.
- Isolation and purification of degradation products.
Relationship with Internal/External Customers & Stakeholders
- Develops and manages strong relationship with internal customers.
- Liases at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and to understand their needs.
Problem Solving Analysis
- With guidance of scientists, performs trouble-shooting on complex issues with respect to the stability of drug substances and drug products.
- Oversees the resolution of more complex issues related to the project.
- Makes complex interpretation and application decisions from test results.
- Refers more contentious issues, with recommendations, to Scientist, Analytical Development.
Leadership/Professional Development of Self & Others
- Continuously upgrades his/her knowledge in pharmaceutical chemistry through review of scientific literature, attendance to training courses, and professional conferences.
- Seeks performance feedback and develops action plans to address performance gaps.
Compliance & Due Diligence
- Performs all work in accordance with all established regulatory, compliance and safety requirements.
- Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
Recognized post secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
BSc with 5 years or MSc with 3 years or PhD with 0-1 years experience in a pharmaceutical lab in an R&D environment.
Knowledge of HPLC method development and method validation.
Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
Working knowledge of GC is an asset.
Good written and verbal English communication skills.
We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.
Other measures Apotex has put into place include (but are not limited to):
staggering employee shifts to reduce the size of work groups
modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines
robust self-assessment and screening tools
non-surgical masks for employees working in GMP areas
strict visitor screening protocol
It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.
For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter
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.