Analytical Chemist

About the role

Eurofins CDMO Alphora develops and manufactures new therapeutics and provides contract research and development services to pharmaceutical and biotech companies, producing bulk drug substances and finished dosage forms. The Analytical Services Department supports synthetic process development, method validation, stability and forced degradation studies, and analytical support for process development. This is a full-time position reporting to the Analytical Chemist Team Leader.

Key responsibilities

• Develop, optimize and author analytical test methods for raw materials, in-process controls, intermediates and APIs to support process development and GMP manufacturing.
• Perform analytical method validations and standard qualification studies, and prepare supporting data, reports and documentation.
• Provide analytical support for process development, including sample analysis and peer review of critical non-GMP analytical data.
• Conduct scientific investigations and analytical testing to support process development, manufacturing and stability programs.
• Author method development reports, stability protocols and stability reports, and perform stability testing and result interpretation.
• Conduct instrument calibrations, performance verifications and routine equipment maintenance.
• Maintain laboratory readiness, organize work areas, follow documentation practices and order supplies and chemicals.
• Work in cross-functional teams (Analytical Development, Quality Control, Quality Assurance, Process Development, Manufacturing) in line with cGMP, safety and quality requirements.

Required profile

• B.Sc. in a related field with at least 5 years of relevant experience in pharmaceutical analysis, development and validation.
• Strong understanding of API analytical method validation and development.
• Excellent technical writing and GMP documentation skills.
• Problem-solving, planning and organizational skills with strong attention to detail.

Required skills

• HPLC, LC/MS, GC, GC/Headspace, GC/MS, UV, IR, KF, TLC, Ion Chromatography
• Proficiency with LCMS and/or GCMS is a definite asset

What we offer

• Approximate annual base compensation of $65,000, with total compensation depending on experience, knowledge and skills.
• Health and dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays and paid time off.