Apotex
Designation : Research Scientist
Function : R&D
Functional Area : Analytical R&D
Job Role 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 Profile :
- 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.
Job Requirements :
- Experience: BSc with 5 years or MSc with 3-4 years’ experience in a pharmaceutical lab in an R&D environment.
- 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.
Work / Job Experience : 3-5 Years
Type of Experience : Analysis of drug product, developmental samples, stability samples, Method Validations
Academic Qualifications :
A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.