Analytical Chemist - Eurofins CDMO Alphora Inc.

Job description

You possess a high degree of initiative and are a team player with excellent communication abilities. You have a strong understanding of API (active pharmaceutical ingredient) analytical method validation and development. You are comfortable in a modern, state of the art laboratory and are proficient with HPLC, GC, IC, KF and various wet chemistry techniques. Proficiency with LCMS and/or GCMS are definite assets. Your attention to detail, a comprehensive understanding of cGMP, strong organizational skills with the ability to drive projects to completion, make you the ideal candidate to become a member of our team. Description of Department: In addition to analytical method validation, stability and forced degradation studies, the Analytical Services Department is responsible for providing analytical method development and analytical support for Synthetic Process Development. Duties & Responsibilities: Reporting to the Analytical Chemist Team Leader, Work effectively within cross-functional project teams, including Analytical Development, Quality Control, Quality Assurance, Process Development, and Manufacturing. 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 for review. Provide analytical support for process development activities, 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. Perform stability testing and interpret results to support product development and manufacturing programs. Conduct instrument calibrations, performance verifications, and routine equipment maintenance to ensure compliance and reliability. Maintain laboratory readiness by keeping work areas organized, ensuring proper documentation practices, and ordering laboratory supplies and chemicals as required. Work in accordance with established cGMP, safety, and company quality requirements. Instrumentation: HPLC, LC/MS, GC, GC/Headspace, GC/MS, UV, IR, KF, TLC, Ion Chromatography B.Sc. in a related field with a minimum of 5 years relevant experience in pharmaceutical analysis, development and validation. Excellent skills technical writing and GMP documentation skills. Excellent problem-solving, planning and organizational skilled coupled with a strong attention to detail.