Job Description

Purpose

The 'Reviewer (Analytical Chemist)' is a key member of the R&D team who will be responsible to review all GMP data generated as a part of testing & other activities carried out in a timely manner as per organization needs. This role would also require preparation of documents as needed. The role would require involvement in the day-to-day activities of the assigned projects & provide support to senior reviewer(s).

Position / Job Title

Analytical Chemist (Reviewer)

Department

AD - R&D

Reporting To

Manager - Research & Development

Location

Concord - Canada

Years of Experience

3 - 6 years

Dosage Form

Nasal / Liquid

Job Responsibilities / Deliverables

Review all GMP analytical data generated as a part of testing

Review of study reports as per requirement

This role would be for an individual contributor

The person is required to work hand in hand with the development & GMP teams of the organization & support other senior Reviewer(s).

The lab activities/ work allocation/ work priorities will be managed by managers & team leads

Audit laboratory documentation for compliance with quality & regulatory guidances

Conduct laboratory investigations and write deviations and LIRs

Participate in method development, method validation, method transfer, stability, characterization, and in-vitro bioequivalence activities for new pharmaceutical products as per requirements

Participate in HPLC and GC testing (including troubleshooting and problem solving) and other required testing on a need basis

Evaluate all results generated for consistency and accuracy

Qualifications & Pre-Requisites

Graduate / Post graduate in chemistry, biochemistry, pharmaceutical sciences or other relevant scientific discipline, or equivalent combination of education and industry experience

3 - 6 years in a relevant industrial environment

Prior experience in a QA/reviewer role: generic or specialty pharmaceutical company; pharmaceutical contract service organization; analytical or formulation laboratory with ANDA directed projects would be as asset

Ability of collaborate & work with the current analytical team members

Possess basic method development / QC review experience to critically review the data generated

Additional notes

The individual may be required to work in the afternoon shift on a need basis

Job Type: Full-time

Benefits:

Dental care Extended health care On-site parking
Schedule:

8 hour shift Evening shift Monday to Friday
Ability to commute/relocate:

Concord, ON L4K 4J1: reliably commute or plan to relocate before starting work (preferred)
Education:

Bachelor's Degree (preferred)
Experience:

Analytical chemist Reviewer: 3 years (required)
Work Location: In person