Formulation Chemist (North Brunswick, NJ) Formulate & design drug products.
Design and execute for the prototype. Pilot batch, ANDA batch formulations. Responsible for pharmaceutical formulation process development and validation. Assist with method development, validation and characterization for multiple products. Perform data reviews, prepare reports and quality documents. Develop liquid and solid oral formulations suitable for oral, buccal, sublingual and parenteral administration Prepare CMC sections of a regulatory filing. Prepare extensive technical reports, SOPs, protocols, regulatory sections in CTD format and other development and CGMP related documents using Quality by Design (QbD) principles and methodologies. Master's degree in Pharmacy with one year of experience. Experience in Instrument & Equipment qualification (DQ, IQ, OQ and PQ protocols). Experience in preparation, generation and execution of Batch manufacturing record (BMR) and Batch Processing record (BPR) for drug products. Experience in implementing Quality Management System as per CGMP and writing technical documents such as SOPs and product development reports. Send resume to API Pharma Tech LLC, 675 U.S. Highway One, Suite #128, North Brunswick, NJ 08902. This position is eligible for the employee referral program.