Key Skills: Scientific & Technical Leadership. Regulatory and Quality compliance. Ensure cost effective process development. Ensure that laboratory work is carried out in a protected manner.
- Ensure that the R&D; unit complies with relevant statutes.
- Lead development of synthetic routes and scale-up processes for APIs and intermediates.
- Guide polymorphism studies, impurity profiling, and characterization using advanced analytical techniques.
- Ensure cost effective robust process chemistry and technology transfer to manufacturing units.
- Manage multiple projects
- Mentor and develop team members, fostering a culture of scientific rigor and continuous improvement.
- Ensure adherence to GMP, GLP, ICH guidelines, and internal SOPs
- Prepare and review documentation for regulatory submissions, including validation protocols, stability reports, and change controls.
- Support in internal audits.
- Plan and execution of experimental work for the assigned project for self and team.
- Interpretation of experimental results and propose directions for further work Troubleshoot the problems in process development
- Record the experimental observations
- Interact with the analytical division for the analysis
- Prepare documents, presentation for review on regular basis
- Promote and enforce EHS guidelines in daily operations.
- Ensure safe handling of chemicals and compliance with environmental standards.
- Drive continuous improvement initiatives in lab practices and documentation.
- Follow the practices and procedures as laid down by statutes.
📌 Senior Research Scientist I (India)
🏢 SRF
📍 India
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