Chemist, Analytical PLCM RD5-GRD-MLCM S

Under guidance of Scientific leader, Analytical Product/Method Life Cycle Management, responsible for performing all activities in evaluation of new alternate API sources, investigations related to commercial methods, compendia method evaluations for any commercial products, and laboratory support work for Manufacturing Technical Services and New Product Launch. This group also responsible for analytical method development and validation for new API source and methods that are related to commercial specifications, comprehensive testing of API and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.

• Under guidance of senior chemist, performs validation of analytical testing procedure for drug substance and drug product.
• As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
• Conducts investigation on unexpected issues as directed and provides solutions to resolve the findings.
• Conducts other tests required for dosage submissions.
• Documents and reports results as per established SOP’s.
• Provides technical support to other department for the responses to requirements of regulatory agencies.
• Refers more contentious issues, with recommendations, to Scientific Leader
• Work as a member of a team to achieve all outcomes.
• 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.

• Education

• Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
• BSc or MSc or PhD.

• Knowledge, Skills and Abilities

• Knowledge of HPLC method validation.
• Knowledge of wet chemistry, analytical bench techniques, Window-based software.
• Knowledge of automated data acquisition systems is an asset.
• Working knowledge of GC is an asset.
• Good written and verbal English communication skills.
• Experience
  • BSc with 1 year or MSc with 0 years or PhD with 0 year experience in a pharmaceutical lab in an R&D environment.