Research Scientist
Desired Experience: 02- 05 Years
Qualification : Masters in Pharmacy (Pharmaceutics)
Candidate Profile Summary:
- 02-05 years of relevant functional experience in process development / Tech transfer activities from FR&D to manufacturing, specifically for parental formulations. Experience of handling Process validation batches / scale- up activities and Process validation for regulatory submission purpose are significant advantage
Process Development Expertise:
- Proficient in performing process development requirements for parenteral formulations / Technology Transfer / Site Transfer / New Product launch campaigns. This role is dedicated to the process development and establish the process during the manufacturing as per the plan of niche and differentiated parental formulations.
Batch Execution and Technology Transfer :
- Responsible for the execution of scale-up and exhibit batches, Ensure the implementation of Good Manufacturing Practices (cGMP) during the manufacturing process.
- Facilitate smooth technology transfer of processes from R&D to Manufacturing and Oversee the other activities associated with technology transfer campaign
- Trouble shooting in exhibit the validation batches and Process Optimization
- Experience with aseptic and sterile process requirements and Strong understanding of formulation development requirements of parental formulations, particularly Injectables / Novel drug delivery systems
- Capable to independently execute the manufacturing requirements of Scaleup / Exhibit batches as per the plan by coordination between FR&D and Manufacturing. Proficient in technology transfer norms and process requirements.
- Understanding the process parameters, experimental design, Stability studies, GMP norms, excipient selection, compatibility studies, Validation requirements and filtration studies are advantageous
- Understanding of the regulatory requirements and Good Manufacturing Processes
- Coordination with cross-functional departments (Manufacturing, Packing, QC, DQA, QA and Engineering) for necessary activities during the scale-up / exhibit batch manufacturing *
- Adherence to the cGMP norms / SOPs and guidelines as applicable for the process development.