|Essential Duties and Responsibilities:
•Responsible for providing guidance for all aspects of formulation development, specifically pre-formulation and formulation studies, scale-up and manufacture of submission/registration batches.
•Providing relevant documentation (product development) for ANDA505b2/NDA filings.
•Conducting background literature research and provides scientific conclusions and recommendations for formulation strategy.
• Leading pre-formulation studies and formulation development of generic products.
•Communicating and presenting development activities, findings and recommendations to management.
•Evaluating complex technical issues as they relate to new concepts, products, equipment or processes for development of new applications.
•Providing documentation to support submission of ANDAs to FDA.
•Mentoring and assisting junior scientists; performs other duties as assigned.
Education and Experience:
•Must have Ph.D. in Pharmacy, Pharmaceutics, Applied Pharmaceutical Sciences or a closely related field plus a minimum of 3 years of progressively responsible experience in the job offered or a related occupation.
•Must have 3 years experience in the area of pre-formulation, formulation and process development of immediate release and modified release solid dosage forms and with writing pharmaceutical development and QoS reports.
Specialized Knowledge and Skills:
•Must have specialized knowledge of pre-formulation/solid state characterization (VTI, SEM, TEM, Texture Analyzer, DSC, TGA, XRD, Rheometer); pharmaceutical equipment and technologies; in-vitro in-vivo correlation to support product development; and bioavailability enhancement.
•Must have proficiency with strategies used in development of First to File (FTF) generic products and proficiency in understanding legal and patent requirements as they pertain to product development.
•Must have ability to work effectively in multi-tasking environment; and ability to motivate candidate with a ""can-do"" attitude.
•Excellent organizational and good record-keeping skills and effective communication skills.
Travel to different client sites is required.
|Kashiv Pharma, LLC|
State or Province