Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.
Key responsibilities of the position include, but are not limited to -
• Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
• Write protocols, reports, methods, standard operation procedures and submission documents.
• Provide analytical support for formulation and process development.
• Conduct instrument troubleshooting.
• Analyze analytical data, identify trends and provide recommendations.
• Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings.
• Conduct laboratory investigations and prepare laboratory investigation reports.
• Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
• Ph.D. in analytical chemistry or related discipline with minimum 0-3 years’ US pharmaceutical experience or M.S. with minimum 3+ years experience.
•Ability to work independently and as part of a team, self motivation, adaptability, and a positive attitude.
• Hands on experience in using HPLC, GC, UV, FTIR, Karl-Fischer titrator, 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.