Job Description

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.
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Job Summary
Under minimum guidance of Scientist/Scientific Leader, 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.
Job Responsibilities

• Develop stability indicative analytical methods for drug substance and drug product as well as the procedures used to determine the residue on manufacturing equipment.
• Prepare draft methods and method validation protocols.
• Perform validation of analytical testing procedure for drug substance and drug product including dissolution methods.
• Evaluate the stability and determines physicochemical properties of the drug substance.
• Evaluate the stability performance of the trial formulations under forced degradation conditions with comparison of the reference product.
• Perform isolation and purification of degradation products.
• Prepare stability reports for forced degradation, proposes degradation pathway and provide recommended storage condition for drug products.
• Provide justification for specification limit of degradation products based on ICH guideline, stability data and compendia requirements.
• Perform releasing tests for bio batches and initial tests for stability batches. Conducts other tests required for dosage submissions.
• Conduct HPLC, GC, spectrophotometer, dissolution apparatus and physical testing by using Chromatographic software and LIMS.
• Document and report results as per established SOP's.
• Provide 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.
• Liase regularly with internal customers to obtain a very detailed understanding their current and future needs.
• With guidance of scientist/scientific leader, perform trouble-shooting on complex issues with respect to the stability of drug substances and drug products.
• Oversee the resolution of highly complex issues related to the project.
• Refer more contentious issues, with recommendations, to Scientist/Scientific Leader, Analytical Development. Make complex interpretation and application decisions from test results.
• Continuously upgrade his/her knowledge in pharmaceutical chemistry through review of scientific literature, attendance to training courses, and professional conferences.
• Seek performance feedback and develop action plans to address performance gaps.
• Provide technical coaching to team member and internal customers. Ensure all advice given to internal contacts and the complex decisions made at this level are compliant.
• Review all type of test methods, validation protocols and validation reports as per SOP approved documents. Ensure all analytical test results and reports generated are according to the test method, protocols, and specific SOPs.
• Prepare and audit Change Control Records (CCRs) in Apotex's Quality Management System (QMS) along with the corresponding documents.
• Work in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

• Recognized post secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
• Knowledge, Skills and Abilities

• Knowledge of HPLC method development and method validation Working knowledge of GC is an asset.
• Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
• Good written and verbal English communication skills.
• Ability to work with a minimum of supervision.
• Experience

• B.Sc with 5 years or M.Sc with 3 years or PhD with 0-1 year experience in a pharmaceutical lab in an R&D environment

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.

Skills Required