Under limited direction and supervision, carry out the formulation, design and development of complex dosage forms, including but not limited to: transdermal, topical, vaginal and other combination products through Abbreviated New Drug Applications (“ANDAs”) and New Drug Applications (“NDAs”) filings. Develops and executes formulation strategies related to product development, including project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (Analytical Sciences, Legal, Regulatory, and Pharm Tech). Maintain a high level of expertise within the field and develops new technologies and concepts to be applied in the development of transdermal, topical, vaginal, and other complex controlled release drug products. Provides technical support as needed to third party projects and conducts technical feasibility assessments for potential new products.
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.
Bachelor’s Degree in Science or related scientific field from an accredited university, and eight (8) years related pharmaceutical experience or an equivalent combination of education and experience.*LI-WK1