Participate in the development of new transdermal systems by providing guidance to formulators in the area of product stability and prevention of degradation. Perform synthesis or modifications of drugs for transdermal applications. Serve as a resource for R&D and company management to answer chemistry related questions arising from new product or troubleshooting projects. Develop and validate stability indicating analytical methods for transdermal systems. Support QA and QC investigation with technical expertise and any required additional testing.
Lead the Analytical support for the development of each assigned new transdermal system by coordinating the development and validation of all test procedures. Coordinate with the Quality Engineering department to determine and set specifications for finished product and raw materials. Manage and provide guidance and direction to scientists and lab technicians. Troubleshoots and resolves complex problems. Manages and is responsible for the results delivered by a team. Develop, validate, and transfer stability indicating analytical methods for transdermal systems. Typically requires at least 3 years of previous Research Fellow experience and proven leadership to be eligible for the Sr. Research Fellow position.
ESSENTIAL DUTIES • Investigate possible degradation pathways of drugs in transdermal systems. Provide information leading to degradant identification, product design and stability improvement. • Provide scientific advice and ideas for transdermal formulations, which could lead to patentable inventions. • Perform syntheses or modifications of drugs for transdermal application. • Develop, validate, and transfer stability indicating analytical methods for transdermal systems. • Comply with all applicable regulations and cGMP standards; Ensure that work performed in area of responsibility is conducted in a safe and compliant manner; Maintain notebooks and proper records in accordance with SOPs and policies. • Perform other duties and special projects as required.
• Lead the Analytical support for the development of new transdermal systems by coordinating the development and validation of all test procedures. • Support commercial product production with technical investigations. • Keep abreast of relevant literature; Extend expertise in dermal/topical formulations and other dosage forms as required. • Write Protocols that outline complex laboratory experiments and validations. • Write reports to summarize projects. • Supervise scientists and significantly contribute to the introduction of new technologies. • May serve as a company witness in legal depositions if required.
EDUCATION / EXPERIENCE: • Ph.D. in Chemistry, Organic Chemistry, Chemical Engineering, or equivalent experience that provides operational knowledge of principles, procedures , methods and techniques of organic chemistry. • Industrial experience on transdermal product analysis: 6+ years for Research Fellow; 11+ years for Sr. Research Fellow. • Demonstrated effective oral and written communication skills. Experience in working in team settings and technical leadership. • Master’s degree with 7 to10 years of experience, or PhD 4 to 7 years of experience. Knowledge of scientific principles, procedures, methods and techniques. Laboratory background with an understanding of chromatographic analysis training and separation theories. Appropriate work experience with proven ability for practical application of theoretical knowledge. • Previous experience of supervising scientific staff is required.
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.Over 450 Noven colleagues are wor...king to advance our business and benefit patients at locations in Miami, FL, New York, NY, and in sales force territories located across the U.S. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's platform for U.S. prescription pharmaceuticals, helping Hisamitsu bring the benefits of patch therapy to the world.Noven CoaterNoven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.