Analytical Chemist

The analytical chemist will be a key member of the R&D team who will be responsible for Analytical method development activities. This role will require method development, document preparation and other activities as required in a timely manner as per organization needs.

Analytical Chemist

AD – R&D

R&D Head

Concord - Canada

5 to 10 years related experience

• Perform routine and non-routine HPLC/GC testing and analysis on pharmaceutical products and raw materials
• Develop and validate HPLC, GC and product performance test methods for pharmaceutical products
• Prepare documents and reports necessary for development and GMP activities.
• Develop specifications for finished product, bulk product, raw material and packaging components.
• Perform analytical method development and method validation for new pharmaceutical products.
• Perform Spray Pattern and Droplet Size Distribution by Laser Diffraction testing for the release of bulk and placebo formulations and for finished product.
• Perform physical/comparative testing on generic and innovator products
• Conduct testing of stability and developmental stability samples
• Evaluate all results generated for consistency and accuracy and notify manager of any trends, atypical results or out-of-specification result
• Perform troubleshooting and problem solving of analytical instrumentation.
• Ensure that work is performed in compliance with GMP, GLP, SOPs, and current test methods.
• Any other duties as assigned

• Masters degree or equivalent in an applicable discipline of science (pharmaceutical sciences, chemistry, biochemistry, chemical engineering, medical laboratory science or related)
• 5 to 10 years of experience in a pharmaceutical R&D laboratory and / or CMO setting
• Experience in method validation, method transfer and method equivalence tests
• Familiar with working with instruments with software, ICH guidance and US pharmacopeia.
• Analytical skills required to handle complex products.
• Experience in development of nasal / liquid products will be an asset.
• Great attitude and motivated to learn new skills.
• Good written and oral communication skills
• Ability to work independently with minimum supervision

• This position may be required to work in afternoon shift on a need basis