Job Description

Role & responsibilities Responsible for formulation and process development (QbD approach) of following categories of Pharmaceutical products: Oral Immediate-Release Dosage Forms. Oral Modified-Release Dosage Forms Including Pelletization technology and Wurster technology. Topical Semisolids (Creams, Ointment and Gels). Oral Liquid Dosage Forms Topical Liquid Dosage forms. Solid (Suppositories), Semisolid & Liquid dosage forms for Rectal and Vaginal applications. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Execution of technology transfer batches for manufacturing processes from laboratory scale to production scale. Oral Immediate-Release Dosage Forms. Oral Modified-Release Dosage Forms Including Pelletization technology and Wurster technology. Topical Semisolids (Creams, Ointment and Gels). Oral Liquid Dosage Forms Topical Liquid Dosage forms. Solid (Suppositories), Semisolid & Liquid dosage forms for Rectal and Vaginal applications. Knowledge of patent non infringing strategy based product development Knowledge of Bioequivalence study & clinical study protocol and criteria Independent contributor for batch planning, batch execution & technology transfer Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches. Responsible for all formulation/ process related CMC documents which will be part of regulatory filings. Write/review master formulas, manufacturing procedures, SOPs, stability protocols, process validation protocols, Product Development Reports etc. Prepare/review specifications for pharmaceutical products and packaging components, etc. Support the manufacturing of exhibit/submission batches per regulatory requirements. Work with Cross-functional teams (Analytical, Regulatory Affairs, Pharmacovigilance, Bioequivalence, Quality Control, Quality Assurance, Inventory Control, etc.) to expedite the development and approval of new products by different Agencies for Regulated and ROW Markets. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs. Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality. Communicate with outside vendors and laboratories. Preferred Skill Set: Thorough knowledge of the pharmaceutical industry, particularly drug delivery industry, and formulation and process development including guidelines. Knowledge for development of formulations comes under category of medical devices, Dietary Supplements and Cosmetics. Knowledge of ICH/GMP regulations. Behavioral /Managerial Skill Sets Skills building and maintaining productive relationships with organizational partners including teamwork. Skills related to develop and deliver products well with in specified timelines. Being a team player Appropriate communication with all stakeholders