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

📌 Analytical Chemist (Vaughan)
🏢 Rubicon Research
📍 Vaughan