|Essential Duties & Responsibilities
•Develop and validation analytical method for drug substances, drug products, and excipients.
•Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
•Write protocols, reports, methods, standard operation procedure, and submission documents.
•Provide analytical support for formulation and process development.
•Perform independent scheduling and coordination of activities.
•Conduct instrument troubleshooting.
•Analyze analytical data, identify trends and provide recommendation.
•Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings.
•Train and provide technical guidance to junior scientists.
•Conduct laboratory investigation and prepare laboratory investigation report.
•Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.
•Evaluate and improve existing test methods.
•Review and evaluate drug substance suppliers technical documents and provide recommendation in API vendor selection.
Education and Experience:
•Ph.D. in analytical chemistry or related discipline with minimum 5+ years US pharmaceutical experience or M.S. with minimum 8+ years experience.
•Posses broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies.
•Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA regulations.
•Hands on experience in wet chemistry techniques.
•Good verbal and written communication skills.
•Attention to details and accurate record keeping.
•Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.
•Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
|Kashiv Pharma, LLC|
State or Province