Apotex Inc. Analytical Development Chemist in Richmond Hill, Ontario
Note: This is a contract position.
Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds. We’d love to hear how you could contribute to the team!
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.
Works 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.
All other duties as assigned.
Key Job Responsibilities
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.
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.
Provides the resolution of more complex issues related to the project.
Works under the guidance of the Scientist, Analytical Development.
Makes 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.
Please note that employment is conditional upon the successful completion of a background check.
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.
System ID: 2016-4872
Job Type: Contract
Job Industry (Choose up to 3 industries): Pharmaceutical
Career Level: Experienced