Chemist, Ad

Job Summary

Under minimum supervision of Scientist, Analytical Development, responsible for performing all activities in analytical method development & validation, and conducting comprehensive testing for API evaluation, formulation evaluation and API releasing for NPD process and submission.

Job Responsibilities

• 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, 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.
• Documents and reports results as per established SOP's.
• 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 and IC, including Chromatographic Data Systems. Knowledge of UV, IR, and Wet Chemistry.
  • 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 GC or LIMS is an asset.
  • Good written and verbal English communication skills.
• Experience
  • Minimum 2 years' experience in a pharmaceutical or analytical lab, preferably in R&D environment.