Chemist, Physical Properties RD8

Apotex•Toronto, ON

13d•CA$73,008 - CA$121,680

About The Position

Perform R&D and Commercial release tests in compliance with GMP and data integrity requirements. Responsible for developing and validating methods for analyzing pharmaceutical active and inactive ingredients using a wide variety of instruments. Interprets analytical data and generates complex scientific reports. In charge of deficiency response. Performs literature search, project evaluation, establishes specifications, and leads new product development projects.

Requirements

Recognized post secondary education in analytical chemistry, organic chemistry, material chemistry, material engineering, pharmaceutical sciences, or related field.
BSc with 7 years or MSc with 5 years or PhD with 3 years’ experience in a pharmaceutical lab in an R&D environment with focus on physical property testing.
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.

Nice To Haves

Knowledge and experience in peptides.

Responsibilities

As a project leader, be responsible for NPD projects and lead junior chemists in product development.
Establish physical properties related specifications.
Evaluate and establish deficiency letter response strategies, conducting testing and drafting deficiency response reports.
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.
Provides expert advice on the decision making of polymorphic forms, material particle size, and other physical properties information to management in new product development, submission, Product Life Cycle Management (PLCM) and patent related issues.
Develop and implement strategies and work plans in the crystalline form preparation, identification and characterization by using various techniques of Powder x-ray diffraction, Thermal analysis (TGA/DSC), Microscope, Particle size analysis, laser particle size and DLS (Dynamic Light Scattering), 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.
Instruct and train staff on the use of new instrumentation. Prepares SOP/WI on operation of new instruments.
Evaluates current analytical procedures and recommends systems and/or modifications to increase laboratory efficiency.
Evaluates analytical instrumentation and software and provides expert opinion on their quality and applicability to Apotex requirements.
Maintains strong relationships with external providers/vendors and customers.
Provides technical expertise and consultation to other Apotex laboratories.
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.
Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.