Research Scientist - Stability Testing Centrenp

Job Summary

Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for new products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.

Job Responsibilities

• 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 other tests required for dosage submissions.
• Documents and reports results as per established SOP s.
• Provides technical support to other department in response to deficiency letters from regulatory agencies.
• 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, Health and Environment policies, and HR policies.
• Liases at peer levels within RD solid dosage to obtain a more in-depth level of expertise and to understand their needs.
• Refers more contentious issues, with recommendations, to Supervisor
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
• All other relevant duties as assigned.

Job Requirements

• Education
  • A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software.
  • Knowledge of automated data acquisition systems is an asset.
  • Knowledge of Auto/Manual dissolution test is an asset.
  • Working knowledge of GC is an asset.
  • Good written and verbal English communication skills.
• Experience
  • BSc with 5 years or MSc with 3-4 years experience in a pharmaceutical lab in an RD environment.

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