Research Scientist - Generic (2 openings available)

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:  Under minimal guidance; and in full compliance with cGMPs, safety and regulatory policies; manufactures experimental, clinical and stability batches of immediate and controlled release solid dosage formulations.  

 

Responsibilities:Lead Product Development team to facilitate the development and commercialization of immediate release and modified release solid oral dosage forms.Designs and undertakes quality scientific experimentation to develop robust solid oral dosage formulations and processes.Designs and conducts stability studies.Interprets in-vitro and in-vivo data to derive clear conclusions and provide direction for future work.  Defines manufacturing processes and writes process study protocols and manufacturing batch records.Manufactures pilot/pivotal clinical and stability batches to support ANDA filings.Prepares CMC documents for ANDA submissions.Responsible for process optimization, scale-up, technology transfer and process validation.Prepares development and process validation summary reports.Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings.Collaborates with multidisciplinary team comprising analytical, quality, and manufacturing functions.Support IMPAX Lab’s Quality System.Other duties as assigned.

 

Qualifications:Ph.D. in Pharmaceutics, Chemical Engineering, Chemistry or equivalent discipline with 0-2 years of relevant experience, or Bachelor’s or Master’s degree and 4-6 years of relevant experience. Basic knowledge of cGMP required.  Basic knowledge and training in using a variety of laboratory and/or scale-up equipment.  Good communication skills both verbal and written.