Chemist, AD RD7

Apotex Inc.; Richmond Hill; On-site; CAD 63,000 - 106,000; Full time

Job summary

Apotex Inc. in Canada seeks an Analytical Development Scientist to perform early development activities, develop and validate analytical methods for new products, and generate regulatory submission data.

You will work as part of the project team and liaise with internal customers to understand current and future needs. Under guidance of scientific leadership, you will execute stability testing, method validation, and degradation studies, and contribute to regulatory documentation and quality

Qualifications

• Recognized post secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
• Experience in pharmaceutical lab R&D with analytical method development and validation.
• Strong written and verbal English communication; ability to work with minimal supervision.

Responsibilities

• Develop stability-indicative analytical methods for drug substance and product, incl. residue on equipment.
• Validate analytical testing procedures for substance and product, including dissolution.
• Evaluate stability and physicochemical properties; assess forced degradation and degradation pathways.
• Prepare stability reports and justify specification limits for degradation products.
• Perform release tests for bio batches and initial tests for stability batches; report results.
• Operate HPLC, GC, spectrophotometer, dissolution apparatus and related software; report results.
• Provide technical support to other departments on stability issues and regulatory responses.
• Collaborate with internal customers to understand current and future needs.

Skills

HPLC

Method validation

GC (knowledge)

English communication

Analytical bench techniques

Education

Bachelor's degree in Analytical Chemistry or related field

Tools

Windows-based software

Automated data acquisition systems

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.

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

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 andaccessible 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 $63,482 - $105,804 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.