Established in 1976, J.B. Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India’s fastest growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally. Today, JBCPL exports to over 30 countries across the world and earns more than half its revenue from its international business.
Job Title : R&D – FDD Documentation – 1 Opening(s)
Experience : 2 – 5 Years
Job Description:
- Patent landscaping by coordination with IP team.
- Planning and Procurement of RLD samples, Excipient, Packaging materials, Equipment, Change parts, Spare parts etc., for both development and scale up batches.
- Execution and evaluation of Preformulation, feasibility, formulation development, formula optimization and process optimization trials.
- Monitoring stability study of development and scale up batches and reviewing data.
- BE study design and protocol review as per requirement of clinical team.
- Documentation and Review of development and technology transfer related documents includes MF/MFC/PDR/Lab note book/Stability protocols.
- Review of Specification of Drug substance, Drug Product, Excipient and Packaging Materials.
- Planning for procurement
- Owing responsibilities in planning and smooth execution of scale up and exhibit batches at manufacturing locations by applying risk assessment and risk mitigation strategies.
- Coordination with regulatory for dossier filing.
- Responding to deficiency query of products under review by regulatory authorities.
- Timely updates of project status to superiors and highlighting milestones and constraints of projects.
- UG – B.Sc – Chemistry, B.Pharma – Pharmacy
- PG – MS/M.Sc(Science) – Chemistry, M.Pharma – Pharmacy
