Essential job duties will include:Timely completion of new product development activities, such as; pre-formulation, developing stable and bioequivalent formulations; developing manufacturing processes for ANDA registration batches; overseeing all ANDA registration batch manufacturing and authoring, reviewing and approving technical documents such as protocols, batch records, specifications and development reports.

Utilize knowledge in cGMP, ICH, USFDA, gas chromatography, HPLC, IR-spectrophotometer, UV-spectrophotometer, AAS. Works with production to manage scale-up, process development and validation. Develops, interprets and explains standard operating procedures and ensures compliance. Maintains effective communication within areas of responsibility. Maintains quality, accuracy and quantity of work; deals with routing problems; develops detailed internal work methods and initiate recommendations. Develops projects as per Directors lead. Identifies and evaluates new products.

 

Please email resume to Christine Banks, Human Relations Representative at christine.banks@apicore.com