Analyze and design pharmaceutical research and product development programs including R&D pre-formulation/characterization-In-vitro model development and IVIVC using GC/GC-HS, HPLC, IVRT/IVPT in-vitro diffusion;  Establish cGMP research laboratory for the research and development of complex pharmaceutical products by applying FDA regulatory schema for cGMP laboratories; Research and validate relevant pharmaceutical projects, including analytical chemistry methods, analytical testing procedures and equipments, and chemical quality assurance protocols using ANDA, CMOs/CROs, CMC-QC, DSC; Analyze and plan strategic research and development activities to support pharmaceutical product development projects; Manage and respond to FDA deficiencies to support product approvals; Supervise 5 staff.

Require Master’s degree in Chemistry, Pharmaceutical Chemistry, or Pharmaceutics plus 1 year experience in job offered.  Require skills and knowledge in ANDA, CMOs/CROs, CMC-QC, DSC, GC/GC-HS, HPLC, IVRT/IVPT in-vitro diffusion.

Job location: Pine Brook, NJ. Submit résumé referencing job code PAB003 to HR, OCIM Pharmaceuticals LLC, 39 U.S. Highway 46, Unit 803, Pine Brook, NJ 07058