Job Description: Handling formulation development of oral solid dosage forms for the US regulatory market and pharmaceutical industry; adhering to the company’s rules and regulations, and active SOPs and cGMPs. Conduct literature search and pre-formulation studies. Supporting the technology transfer of formulation and process from the development site to manufacturing site. Designing and executing experiments, employing quality by design (QbD) principles; Preparing chemistry-manufacturing control (CMC) documents (PDR/QOS, etc.) for regulatory submissions/ANDA filings. Preparing drug substance/in-process/finished product/stability specifications and its justifications as per US FDA/ICH guidelines. Optimizing formulation with respect to composition, important process parameters for achieving desired Target product profile. Based on formulation optimization studies, deriving a formulation meeting Target Product Profile. Providing pre-formulation, formulation, and pharmaceutics principles required to get bioequivalence of the drug product. Execute experiments to support the development of solid oral dosage forms as defined by the supervisor and maintain the formulation development lab notebooks. Conduct formulation feasibility and process optimization studies, prepare pilot batch documentation, ensure availability of raw materials, and complete batch documentation as required. Coordinating with other related departments like Quality Control, Quality Assurance, Engineering and Regulatory Affairs. Performing reverse engineering in the development of pharma products. Handle characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs. Reviewing and analyzing patents and providing the technical approaches for ANDA product development without interfering with the innovator patents. Preparing elemental impurities and Nitrosamine impurities assessment reports. Applying chemical engineering principles in developing new products. Requirements: Master’s degree in Pharmaceutical Sciences, Pharmaceutics or Pharmaceutical Technology (or its U.S. Equivalency). Two (2) years’ experience in Pharmaceutical Research and Product Development. Experience must include: Formulation Research and Product Development activities of Generic Specialty Formulations of Immediate release tablets, Extended release tablets Osmotic drug delivery systems, Delayed release oral solid dosage forms, solutions, suspensions, Capsules and ointments; Preparing chemistry manufacturing control (CMC) documents (PDR/QOS/BMR) for regulatory submissions; Review/analysis of patents and development of patent noninfringement dosage forms. Designing and executing experiments, employing quality by design (QbD) principles. Formulation development of different dosage forms for ANDA submission; experience in reviewing of SOP’s and procedures. Preparation of Process Evaluation Protocols, Batch Production Records, and Validation/Exhibit batch summary; Preparation and evaluation of Scored tablets /Split tablets as per FDA guidelines. Preparation and evaluation of Nitrosamine impurities and Elemental impurities in Drug substances/drug products. Preparation of drug substance/in-process/finished product/stability specifications & its justifications as per US FDA / ICH guidelines, experience in technology transfer of formulation and process from the development site to manufacturing site; Knowledge of current US FDA / ICH guidelines. Hands on experience of equipment handling like high shear granulator, hot melt extruder, Bilayer compression machine, Capsule filling machine, Coating Machine, Laser drill machine, and fluid bed processor (GPCG). 40 hours per week. M-F: 9:00 a.m. to 5:00 p.m. Must have proof of authority to work in the United States.