R&D Chemist - Structure Elucidation & Regulatory Reports

Apotex Inc.; Toronto; On-site; CAD 63,000 - 106,000; Full time

Benefits offered by this job

Total Rewards package

Bonus programs

Comprehensive benefits

Pension plan

Learning and development opportunities

Job summary

Apotex Inc. in Toronto, Ontario seeks an experienced scientist to issue and review complex technical reports and develop specifications for new drug substances and products in collaboration with Analytical Development.

The role supports regulatory submissions and deficiency responses globally. The candidate should hold a PhD/MS/BS in chemistry, with strong analytical skills (HPLC/LC-MS, GC, NMR) and familiarity with GMP/GLP/GDP and ICH/FDA guidelines.

Qualifications

• PhD or MS or BS degree in organic, analytical or physical chemistry (or related field).
• Strong knowledge of physical and analytical chemistry techniques and data interpretation.
• Ability to write scientific reviews/reports clearly.
• Familiarity with GMP, GLP and GDP; regulatory requirements (ICH, FDA).
• Experience with spectral and instrumental data analysis.

Responsibilities

• Review drug master files and write raw material evaluation reports.
• Evaluate analytical impact of supplier changes for API.
• Develop and justify specifications for drug substances/products and in-process specs.
• Prepare physico-chemical reports and respond to regulatory deficiency letters.
• Support change controls and stay updated with regulatory trends.

Skills

HPLC/UPLC

GC

NMR

LC-MS

IR

UV

DSC

TGA

XRPD

Education

PhD/MS/BS in organic/analytical/physical chemistry

Tools

GMP/GLP/GDP

ICH/TPD/FDA guidelines

Job description

Apotex Inc. in Toronto, Ontario seeks an experienced scientist to issue and review complex technical reports and develop specifications for new drug substances and products in collaboration with Analytical Development.

The role supports regulatory submissions and deficiency responses globally. The candidate should hold a PhD/MS/BS in chemistry, with strong analytical skills (HPLC/LC-MS, GC, NMR) and familiarity with GMP/GLP/GDP and ICH/FDA guidelines.