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Research Chemist
3 months ago
About Apotex Inc.
Apotex Inc. is a globally recognized health organization based in Canada, dedicated to producing high-quality and affordable pharmaceuticals for patients worldwide. With a workforce of nearly 7,200 individuals engaged in manufacturing, research and development, and commercial operations, Apotex ensures that its medicines are accessible in over 75 countries. The company focuses on the development and marketing of generic, biosimilar, and specialty products through vertical integration.
For more information visit: .
Job Overview
Conduct testing on Raw Materials, In-Process Samples, Finished Products, and Stability Samples. Collaborate with the Analytical Development department to perform co-validation of analytical methodologies. Prepare and submit audited stability summary reports. Maintain and update stability schedules for various pharmaceutical products. Ensure compliance with the Ontario Occupational Health and Safety Act, Safe Work Procedures (SWPs), and Apotex's Health, Safety, and Environmental policies. Adhere to all Apotex Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) requirements.Key Responsibilities
Operate with minimal supervision to analyze raw materials, in-process samples, finished products, and stability samples with a high level of accuracy and precision using established analytical techniques and instruments.
Document findings clearly in accordance with SOPs.
Provide statistical analysis of test results as necessary.
Organize tasks efficiently and manage time effectively.
Communicate technical information clearly and concisely, both verbally and in writing.
Under supervision, perform intermediate precision assessments as part of method transfer in collaboration with Analytical Development method validation.
Undertake additional responsibilities as assigned by the supervisor.
Technology and Instrumentation
Proficient in using UV-VIS spectrophotometers, Karl Fischer titrators, auto-titrators, HPLC, GC, IC, balances, vacuum ovens, microscopes, osmometers, density meters, Hunter scan, and auto-actuation stations. Familiarity with more complex techniques as required.Methodological Design
Review specifications, testing procedures, and SOPs prior to implementation and provide feedback as necessary.Collaboration with Internal and External Stakeholders
Serve as a key contributor within the team and assist senior chemists during challenging tasks. Regularly communicate with internal customers to understand their requirements and keep them informed of work progress.Problem Solving and Analysis
Independently resolve routine issues. Identify complex problems related to instruments, specifications, and testing methods, and escalate them to senior personnel for resolution.Decision Making and Autonomy
Address inquiries from junior chemists and participate in training new staff as needed.Professional Development
Continuously enhance technical knowledge by attending relevant seminars or courses.Compliance and Due Diligence
Conduct all activities in compliance with SOPs, cGMP, and SHE standards. Participate in the review of departmental policies, procedures, and standards that impact their area as required.Qualifications
Bachelor’s degree in Chemistry or a related field. A minimum of 3 years of experience in a pharmaceutical analytical laboratory. Possess laboratory computer skills.(b) Operational and troubleshooting skills related to analytical instruments.
(c) Strong understanding of GMP, GLP, and WHMIS.
(d) Good knowledge of pharmaceutical compendia.
At Apotex, we are dedicated to creating an inclusive and accessible work environment where all employees feel valued, respected, and supported.
Apotex provides accommodations for applicants with disabilities as part of its recruitment process. If you are contacted to arrange an interview or testing, please inform us if you require accommodations.