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