Associate Director, Generic Product Development

Impax Laboratories, Inc. is a technology based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.

 

Job Summary: Supervises 5-15 formulation scientists and leads the development of multiple solid oral dosage form formulations in both immediate release and controlled release area. 

 

Responsibilities:

·  Manage the Generic Product Development group responsible for the development of stable oral dosage forms through filing of ANDA and product commercialization.

·  Responsible for all aspects of product development, from proof of concept experiments to commercialization, including formulation and process development and optimization, scale up, process validation, technical transfer and continual technical support.

·  Determine the development strategy, including: selecting formulation technology platforms, setting in-process controls and specifications, clinical batch manufacture, evaluation and interpretation of stability data, alternate supplier qualification and selection of optimum container/closure system.

·  Manage the development and technical transfer activities for contract research organizations.

·  Responsible for writing technical summaries and development reports, author/review/approve cGMP-compliant documentations (SOPs, manufacturing batch records, stability, cleaning and process validation protocols).

·  Preparation of and defending of, the Chemistry of Manufacturing and Controls section of the ANDA.

·  Provides cGMP and technical training for junior members of staff

 

Qualifications:Ph.D. in Pharmaceutics, Chemical Engineering, Chemistry or equivalent discipline with 5+ years and preferably 8 years or more relevant experience in product development or Bachelor’s or Master’s degree with 15+ years of related experience and/or training.Experience in solid dosage formulation preferred.Experience with pharmaceutical processes and equipment are essential.Must be flexible and able to work on a variety of projects simultaneously.Ability to interact effectively with people over a wide range of disciplines.Experience in managing and/or mentoring PhD and BS/MS level professionals is preferred.Good communication skills, both verbal and written.