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.
Kashiv Pharma is looking for a Scientist I or II to join the Analytical Research and Development Team.
Essential Duties & Responsibilities
Key responsibilities of the position include, but are not limited to –
• Develop and validation analytical method for drug substances, drug products, and recipients
• 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.
• 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
• Conduct laboratory investigation and prepare laboratory investigation report.
• Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
Education and Experience
• Ph.D. in analytical chemistry or related discipline with minimum 0-5 years’ US pharmaceutical experience or M.S. with minimum 3+ year’s experience.
Specialized Knowledge and Skills
• 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.
Work Environment & Physical Demands
General work environment and physical demands as required to successfully performing the essential functions of this job. Ability to work flexible hours as needed. Some travel may be involved.
Supervisory Responsibility, if any: no