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Job Summary: Analytical Development Scientist responsible for performing activities in early development research, analytical method development and validation for new products, comprehensive testing of API and finished dosages, and preparation of regulatory submission documentation.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. With a strong focus on vertical integration, the company develops and sells generic, biosimilar and specialty products.

This role is a key member of the project working team, 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 preparation of regulatory submission documentation.

• Develops working plans for assigned projects and provides timelines to Scientific Leaders.
• Develops stability indicative analytical methods for drug substance and finished product.
• Applies AQbD approach to analytical method development where applicable.
• Prepares analytical methods, validation protocols, method development reports and technical reports.
• Performs validation of analytical testing procedures for drug substance and drug product, including dissolution methods.
• Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance with laboratory SOPs and guidelines.
• Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation.
• Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution.
• Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.
• Conducts other tests required for dosage submissions.
• Conducts lab investigations as a lead investigator for OOS and OOT results.
• Performs investigations and provides reports to other business units within PD-solid dose.
• Provides technical support to other departments for issues related to the stability of drug substances and drug products or for responses to requirements of regulatory agencies.
• Works as a member of a team to achieve all outcomes.
• Develops and maintains strong relationships within Analytical R&D to ensure that projects are delivered on time.
• Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements.
• Ensures all instruments assigned with responsibility within the group/department are well maintained.
• Demonstrates corporate values in the performance of work and interactions with others.
• Performs additional related duties as assigned, in accordance with job responsibilities and necessary departmental objectives.
• Works in a safe manner, collaborating as a team member to achieve all outcomes.
• Demonstrates behaviours that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
• Ensures 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.

• Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
• Good knowledge of instrumentation, such as HPLC, GC, spectrophotometer and dissolution apparatus.
• Good knowledge in HPLC method development and method validation.
• Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
• Working knowledge of LIMS.
• Good written and verbal English communication skills.
• Leadership skills are an asset.
• BSc with 6 years or MSc with 4 years or PhD with 2 years' experience in a pharmaceutical lab within an R&D lab environment.
• Chromatographic method development and validation.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.