Chemist

OverviewJoin to apply for the Chemist role at Apotex Inc..About ApotexApotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.For more information visit: www.apotex.com.Job SummaryWith guidance of Scientist, 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 preparation of regulatory submission documentation. Acts as a key member in the project working team.Job ResponsibilitiesPrepares working plan for assigned projects and provides timeline to Scientific Leader.Develops stability-indicating analytical methods for drug substance and finished product.Works with Scientific Leader to prepare analytical methods, validation protocols 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 protocol 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 for OOS and OOT results.With guidance of scientists, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products.Documents and reports results as per established SOPs.Provides technical support to other department for issues related to the stability of drug substance and drug product or for responses to regulatory agency requirements.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 within group/department are well maintained.Demonstrates corporate values in the performance of the work and interactions with others.Performs additional related duties, as assigned, in accordance with job responsibilities and departmental objectives.Works in a safe manner, collaborating as a team member to achieve all outcomes.Demonstrates behaviours that exhibit 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.All other relevant duties as assigned.Job RequirementsEducation Recognized post-secondary education in analytical chemistry, organic chemistry, biochemistry , pharmaceutical sciences, or related field. Knowledge, Skills and Abilities Knowledge of instrumentation such as HPLC, GC, spectrophotometer, GC/MS, and LC/MS. Knowledge in organic chemistry and MS/MS for unknown structure identification. Knowledge in HPLC method development and method validation. Knowledge of peptide analysis including peptide sequencing by mass spectrometry. Working knowledge of Nitrosamine impurity analysis. Knowledge in HPLC method development and method validation. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. Hands-on experience with GC/MS, LC/MS. Chemical structure elucidation and unknown identification. At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected and supported. Apotex offers 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.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical Manufacturing #J-18808-Ljbffr