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Scientist Sr. - Formulation
*Identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.
*Designs experimental plans and performs pre-formulation and formulation development work on transdermal, topical, ophthalmic, sublingual, vaginal, and other complex controlled release/combination dosage forms.
*Generates and reviews analytical data to support the product development work.
*Writes experimental designs to carry out process development and evaluation work, limited scale-up in support of ANDA’s and NDA’s submission to regulatory agency.
*Plans appropriate analytical testing and stability studies on experimental batches.*
Performs appropriate documentation and prepares pharmaceutical product Formulation Transfer reports, elements of Quality by Design (QbD) and other necessary documents to support regulatory filing of ANDA’s and NDA’s.
*Surveys the scientific literature and performs patent searches to remain current with recent developments in the generic and branded pharmaceutical research and regulatory arena and novel drug delivery systems.
*Evaluates bioequivalence data to recommend changes in formulation, if needed.*
Maintains appropriate documentation of primary data record, report sheets and laboratory notebooks as required by Standard Operating Procedures.
*Participates as a technical advisor as required on third party projects.Provides technical feasibility assessments of potential new products. Provides scientific and technical direction to junior staff members (Scientists and Technicians) to ensure project deadlines and performance standards are met.
Qualifications Nine (9) years related pharmaceutical laboratory experience or an equivalent combination of education and experience. Knowledge of:
*Advanced knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, biopharmaceutics and statistical designs.
*Product formulations, product stability, packaging, and FDA submission methods and practices.
*Product design of transdermal, topical (gels, creams, solutions), vaginal and other combination dosage forms. Knowledge of buccal, sublingual, and ophthalmic products is desirable.
*Quality by Design concepts and principles.
*Business, scientific and personal computer hardware and software applications.
*Business English usage, spelling, grammar and punctuation.
*Leadership and training practices and methods.
*Current Company policies, practices and procedures, including safety rules and regulations.
Education Bachelor’s Degree in Science or related scientific field from an accredited university.
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