Chemist, AD RD7

Job Summary

With 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 Responsibilities

• Designs MS-friendly LC / GC Methods and performs LC/GC-MS/MS analysis of drug substances and drug products, including Nitrosamine impurities, genotoxic impurities, and peptides.
• Prepares working plan for assigned projects and provides timeline to Scientific Leader.
• Develops stability indicative 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 procedure 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 of laboratory SOP 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 the issues related to the stability of drug substance and drug product or for the responses to requirements of regulatory agencies.
• Work as a member of a team to achieve all outcomes.
• Develops and maintain strong relationships within Analytical R&D to ensure that the 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 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 necessary departmental objectives.
• Works 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 the instrumentation such as HPLC, GC, spectrophotometer, and dissolution apparatus.
  • Wet chemistry and analytical bench techniques.
  • Knowledge in HPLC method development and method validation.
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
  • Strong theoretical background in analytical chemistry and organic chemistry paired with an expert knowledge of mass spectroscopy and chromatography.
  • Advance knowledge of peptide analysis by mass spectrometry.
  • Advance knowledge of analytical instrumentation including HPLC, LC-MS and GC-MS.
  • Working knowledge of LIMS is an asset.
  • Good written and verbal English communication skills.
• 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.