Process Development Lead
5 days ago
Company Overview:
Profile HR Consultants Private Limited is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry's chemistry needs. With a presence in over 80 countries, our organization has established itself as a key player in the global market.
Key Deliverables:
- Lead R&D CRO projects for global customers, including development of non-infringing routes for APIs with sustainable processes, including impurity synthesis.
- Develop robust, scalable, operationally safe, and commercially viable processes, including synthesis route selection, lab feasibility, process optimization, technology transfer, and scale-up & commercialization for tonnage-scale campaigns, ensuring close attention to safety and quality.
- Head a team of R&D scientists (M.Sc./Ph.D.) for process development using the QbD/DoE approach and validations, end-to-end troubleshooting, cost reduction, and technology transfer activities, first-to-file product filings.
- Regulatory filing of APIs and regulatory deficiency response of APIs.
- Ensure vendor qualification requirements for procuring KSMs, reagents, and advanced intermediates, investigations (OOS & OOT), and CAPA implementation, change controls.
- Cross-functional engagement with QA, QC, production, and regulatory departments.
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