Research Associate - Pharma Research OOD

Manufacturing of batches for developing the calibration models and support required for Procurement and implementation of Bruker’s FT-NIR at NGP-OSD for release of Commercial batches

Development of novel controlled release as well as non-infringing formulations (solid, liquid) for complex generics and first to file Para IV ANDAs for advanced (US, EU and Australia) and semi regulated markets with QBD approach.

Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations.

Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures.

Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation.

Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries.

Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company.