Technology Transfer

Experience in Documentation, Issuance, CCF, Trackwise, SOP preparation, well versed with GMP and Regulatory requirements of USFDA, EU, ANVISA, AQA.

Bachelor or Master degree in Pharmacy with a specialization in Pharmaceutics or Pharmaceutical Technology. Responsible to Organize and Co-ordinate Training Activities, Preparation of documents and Maintenance of training records. Responsible for material code initiation.

B.Pharma/M.Pharma; Site Transfer of approved products from one facility to another facility. Evaluation and Selection of Optimal batch sizes for scaling up using scientific scale up techniques as guidance based on manufacturing process and equipment capacities for Registration batches and Launch commercial production.

Experience in prior art searches in different domains of life sciences- medical biotechnology, industrial biotechnology, pharmaceuticals, agriculture, biomedical devices. Ph.D. / M.Sc. in Biotechnology / Life Sciences from a recognized University/ Institute

FR&D Department / Technology Transfer / Project Management - Injectables; Evaluation of impurity profiles of drug substance and drug product. Hands on experience with development of Injectable solutions, lyophilized drug products and other complex Injectables.