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

Responsibilities:

• Potency, Assay, Content Uniformity and Impurities testing by HPLC under instructions.


• Development of stability indicating HPLC methods.


• GC, IR, UV, TLC and/or other wet chemistry techniques.


• 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.

Requirements:

• 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.