Purpose 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.
Position / Job Title Analytical Chemist
Department AD - R&D;
Reporting To R&D; Head
Location Concord - Canada
Years of Experience 5 to 10 years related experience
Dosage Form Solid/Nasal / Liquid
Job Responsibilities / Deliverables 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 current 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
Qualifications & Pre-Requisites 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
Additional notes This position may be required to work in afternoon shift on a need basis
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📌 Analytical Chemist (Ontario)
🏢 Rubicon Research
📍 Ontario
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