Job Title

ob Description Job Summary We are seeking a dynamic and experienced Specialist in Formulation Development team responsible for execution and development of Oral Solid/Liquid formulations as per project timelines, ensuring successful pilot & pivotal bio study, robust scalable product development, support filing through approval of the product, coordinate and work closely with various CFTs like analytical team, SCM, process team, COE bio, CPPK, regulatory team, etc. during the course of development through approval. He or She shall work on differentiated formulations and develop them in-line with QbD principles with major focus on Emerging and India market reporting to the Tech lead Formulations.Roles & Responsibilities You will be responsible for discussion and planning strategies for product development, executing them and recording them in E-Lab notebook. Identify and proactively discuss potential challenges along with possible way forward. Collaborate and coordinate with analytical team for batch analysis followed by data analysis from time to time. Relevant documentations for license application and executions of pilot plant batches, stage gate clearances from time to time. Biweekly present project status to the delivery manager. Coordinate with process teams for optimization trials, plant presentations, preparation and review of plant documents and scale up the product from lab scale to exhibit scale/commercial scale. Support filing the product with PDR, support deficiency responses and submission of exhibit batch samples for pharmaceutical examinations/clinical studies, etc. Follow company systems and processes compliance to safety and quality. Qualifications Educational qualification:Masters/Ph.D in pharmaMinimum work experience:7 - 10 years of experience in Oral Dosage Formulations.Skills & attributes: Technical Skills Having worked on Differentiated Solid Oral Dosage Forms, platform technologies, hands on experience on modified release pellets and matrix formulations can be preferred. Hands on experience on lab scale and plant scale equipment's used in manufacturing of Oral solids and liquid formulations. Shouldering end-to-end responsibilities of product development team. Demonstrates data analytical and problem-solving skills. Know how on ICH guidance's, regulatory requirements for regulated and semi-regulated markets, cGMP and cGLP practices. Behavioral Skills Overall communication and presentation skills. Strong analytical and problem-solving abilities. Result oriented. Ability to work collaboratively with own team and cross-functional teams. Committed to continuous learning.