Analytical Chemist

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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- 3 to 7 years related experience

Dosage Form –Solid/Nasal / Liquid

Job Responsibilities / Deliverables

• Develop and validate HPLC, GC and product performance test methods for pharmaceutical products
• Prepare documents and reports necessary for development and GMP activities.
• Perform lab investigations for OOS/ OOT/ Incidents as per regulatory requirements
• Develop specifications for finished product, bulk product, raw material and packaging components.
• Perform analytical method development and method validation for new pharmaceutical products.
• 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

• B.Sc. degree or equivalent in an applicable discipline of science (pharmaceutical sciences, chemistry, biochemistry, chemical engineering, medical laboratory science or related)
• 3 to 7 years of experience in a pharmaceutical R&D laboratory and / or CMO setting
• Experience in method validation, method transfer and method equivalence tests
• Prior experience with scientific documentation (preparation/ review of protocols/ reports) will be preferred
• Experience in handling lab investigations will be an asset.
• Familiar with working with instruments with software, ICH guidance and US pharmacopeia.
• Analytical skills required to handle complex products.
• Experience in development of nasal products will be an asset.
• Great attitude and motivated to learn new skills.
• Good written and oral communication skills

Additional notes

• This position may be required to work in afternoon shift