Formulation Scientists (Cranbury, NJ)

Design and formulate pharmaceutical products involving solid oral dosage forms, liquid and dispersed-phase systems for filing ANDAs; Perform technology transfer and execution of Exhibit batches and process validation batches using QbD; Conduct literature and patent research to analyze and evaluate active and inactive ingredients for generic pharmaceutical drug formulation development; Review, edit and approve documentation including Change Controls, MBRs, Process Validation Protocols, Process Validation Reports and Investigations for new product launch of generic pharmaceutical products; Conduct Root Cause Analysis, CAPA; Conduct stability studies to optimize process parameters for scale-up from lab prototypes to pilot and commercial scale; Analyze and develop specifications and troubleshooting for scale-up and technology transfers; Author and review Manufacturing Batch Records, Packaging Records, Labeling/Scale-Up Batch records, protocols and complete Product Development Reports for/per FDA/ICH guidelines.

Requirements

Must have a master’s degree in Chemistry, Pharmaceutical Science, or Pharmaceutical Chemistry plus 2 years experience in job offered. Require skills and knowledge in ANDA, Technology Transfer, Formulation development, new product launch, Process Validation, Scale up, QbD, FDA/ICH guidelines.

Job Location

Cranbury (NJ)

Submit résumé referencing job code ADP002 to HR, Eywa Pharma, Inc., 2 Research Way, Floor 3, Princeton, NJ 08540.