Job
Description
Role: Formulation Researcher II Work location: Ambernath Role & responsibilities Work on bench with the formulation development teams for the timely achievement of key milestones. Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE. Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data To conduct literature review, prior art experiment design of the product identified for development. Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering. Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic form phase transformation studies, selection of excipients and process as per strategy. Conducting and performing the development trial at bench level, problem identification & resolution. Review and interpretation of analytical data for further action plan. Responsible for execution of Pilot BE batches and interpretation of bio results. Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results. Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE). Establish the stability data for development batches in collaboration with the analytical team. Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report. Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product. Compilation and preparation of pharmaceutical development report with respect to current QbD format. Responsible for preparation of Product Developmental Report (PDR) for filling. Handling of deviations, change control and OOS related to Exhibit batches. Preparation, updating of SOPs. Maintaining of batch, calibration and other necessary records. Subjecting required batches to stability studies. Successful demonstration of proof of concept and ensure prospective documentation in line with QbD paradigm. Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products. Experience & Qualification: Ph.D. in Pharmaceutical Sciences with 3 Yrs +/ M. Pharm in Pharmaceutical Sciences with 6 to 10 years from reputed universities Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada. Formulation Development of Solid Oral Dosage forms, exposure from development and submision to regulatory agencies. SME within team and Provides solutions to moderate problems within team. Frequent use of scientific theories and principles. Good learning acumen Basic level understanding on recent ICH, regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc. Interested candidates can share their CV to ankita.sonawane@teva.co.in Show more Show less
