Scientist I/II - Analytical R&D

Company Name:
Kashiv Pharma, LLC.
Bridgewater, NJ
Kashiv Pharma, LLC offers expert research and development services to the pharmaceutical manufacturing community.
Focused on innovative delivery technology, the company provides clients with vital scientific expertise for analyzing and developing difficult or complex dosage forms and drug delivery systems.
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.
Date: 2014-09-19
Country: US
State: NJ
City: Bridgewater
Postal Code: 08807

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