R&D Head (mAbs)

Job Description

Job Description (Head R&D) 1) To build and direct a team for the development of processes for the commercial manufacture of plasma derived therapeutic proteins. The responsibilities will include the following; a) Identification of plasma derived products that can be developed for commercialisation. b) Review of published literature including patents to understand the existing product, process and formulation. c) Plan the development of scalable processes for the purification and formulation of proteins from human blood plasma. d) Plan for process validation, packaging material development, stability studies, alternate vendor development studies. e) Coordinate training, scale-up and technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.