About Apotex Inc.
Apotex Inc. is a leading Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees, Apotex operates in manufacturing, R&D, and commercial sectors, delivering products to over 75 countries. Apotex specializes in generic, biosimilar, and specialty pharmaceuticals. For more details, visit www.apotex.com.
Job Title: Analyst – Analytical Development (R&D)
Job Summary:
The Analyst – Analytical Development will plan and execute analytical method development, validation for new products, and comprehensive testing of APIs and finished dosages. This role ensures compliance with regulatory requirements and safety protocols, prepares regulatory documentation, and supports technology transfers.
Key Responsibilities:
Method Development & Validation:
Develop stability-indicative analytical methods for drug substances and finished products.
Prepare and execute validation protocols and reports for analytical methods in compliance with cGLP, SOPs, and regulatory guidelines.
Conduct analytical tests including assay, degradation products, dissolution, and physical testing for APIs and drug products.
Documentation & Compliance:
Prepare, maintain, and archive regulatory submission documents, SOPs, protocols, and validation reports.
Ensure timely, accurate documentation of lab investigations, deviations, and change controls.
Technology Transfer:
Support and manage the transfer of analytical procedures between departments and facilities.
Collaborate on technology transfer and method verification activities.
Quality Systems & Troubleshooting:
Ensure adherence to departmental quality systems and cGLP.
Conduct troubleshooting for complex issues in stability testing and instrument performance.
Instrument Maintenance:
Maintain and calibrate laboratory instruments, including HPLC, GC, spectrophotometers, and dissolution apparatus.
Team Collaboration & Training:
Develop strong interdepartmental relationships to ensure project timelines.
Participate in mandatory training and promote knowledge sharing on cGMP and regulatory standards.
Job Requirements:
Education:
Bachelor’s (BSc) or Master’s (MSc) degree in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field.
Experience:
BSc with 5 years or MSc with 3-4 years of pharmaceutical lab experience in an R&D setting.
Proficiency in chromatographic method development and validation.
Skills & Abilities:
Expertise in HPLC, GC, spectrophotometry, and dissolution testing.
Knowledge of cGMP, regulatory guidelines, and troubleshooting analytical methods.
Familiarity with LIMS and automated data acquisition systems is an asset.
Strong written and verbal communication skills in English.
Why Join Apotex?
Inclusive and accessible workplace where employees feel valued and supported.
Competitive benefits and opportunities for professional growth.
Committed to ethical practices, safety, and innovation.
Accommodation:
Apotex provides accommodations for applicants with disabilities as part of its recruitment process. If contacted for an interview or testing, please advise if accommodations are needed.
Take the next step in your career with Apotex Inc., where collaboration, perseverance, courage, and passion drive success.
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