Chemist, Physical Properties RD7

Job Summary

Perform R&D and Commercial release tests in compliance with GMP and data integrity requirements.  Responsible for developing and validate methods for analyzing pharmaceutical active and inactive ingredients using a wide variety of instruments.  Interprets analytical data and generates complex scientific reports.  Performs unknown particles identification and specialized type of investigations on physical properties.

Job Responsibilities

• Develop, validate and technology transfer testing methods for R&D and commercial release. Issue method development summary, validation and technology transfer protocols and method validation and technology transfer reports. 
• Establish and develop testing strategy by using state-of-the-art Physical Properties laboratory instruments for pharmaceutical drug substances and products. Develop and support other Apotex labs special investigation requests with various analytical techniques as required. 
• Evaluate pharmaceutical drug substance, drug products and excipients and provide expert advice on the decision making of polymorphic forms, material particle size, and other physical properties information to management in the new product development, submission, Product Life Cycle Management (PLCM) and patent related issues.
• Develops and implements strategies and work plans in the crystalline form preparation, identification and characterization by various techniques including Powder x-ray diffraction, Thermal analysis (TGA/DSC), Microscope, Particle size analysis, laser particle size and DLS, FT-IR, Microscope FT-IR, FT-IR/NIR image system, ATR, Surface/material characterization (Nitrogen BET surface area and dynamic vapor adsorption), Inductively Coupled Plasma (ICP) – ICP-OES and ICP-MS and the use of general analytical instruments.
• Maintain strong relationships with external providers/vendors and customers.
• Identifies root causes of challenge projects. Investigates and recommends the usage of new or unconventional problem solving techniques to the next level.
• Establishes performance criteria for new and existing analytical instrumentation/systems.
• Keeps updated with new analytical techniques through literature, seminars, workshops etc.
• 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.
• Training new chemist on various lab equipments.

Job Requirements

• Recognized post secondary education in analytical chemistry, material chemistry, material engineering, organic chemistry, pharmaceutical sciences, or related field.
• BSc with 5 years or MSc with 3 years or PhD with minimum 1 year experience in a pharmaceutical lab in an R&D environment with focus on physical property testing.
• Preferred to have knowledge in peptides.
• Advanced knowledge of analytical and physical chemistry, pharmaceutical solid dosage forms.
• Demonstrated technical proficiency, scientific creativity, teamwork, and independent thought.
• Excellent written and verbal communication skills.