What are the responsibilities and job description for the Senior Analytical Chemist position at Germer International - Pharmaceutical Recruiting?
Join a dynamic U.S.-based pharmaceutical startup where your expertise in analytical chemistry will drive groundbreaking innovations in drug substance development and manufacturing. Our client is seeking a passionate, driven scientist who is ready to make an impact in a fast-paced environment.
Essential Job Duties & Responsibilities
- Independently conduct analytical method development, validation, and project support
- Identify technical challenges during analytical method development and perform analytical method troubleshooting
- Responsible for data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor
- Identify and implement new techniques and instrumentation to expand internal capabilities
- Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents
- Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial material
- Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures
- Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development
- Manage day-to-day laboratory activities for analytical equipment
Experience & Qualifications
- P.D. with a minimum 5 years of experience in analytical method development, validation and API and/or drug product development activities regulated by FDA, M.S with a minimum 7 years of experience, or B.S. degree with a minimum 10 years of experience
- Experience with common analytical techniques such as: HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS, Raman, FTIR
