Research Scientist Tech Transfer Kukatpally (India)

Provide technical support to internal sites and CMOs, ensuring validated processes. Act as technical expert during technology transfer and scaleup activities. Apply science and riskbased approaches to maintain sustainable product quality. Review and approve technical documentation (BMRs, Process Validation protocols/reports, Stability protocols/reports, risk assessments, validation documents, RA documents) for timely submission. Execute and monitor batches, applying scaleup factors for process optimization. Maintain oversight of CQAs, CMAs, and CPPs to ensure process robustness. Support validation strategies, including protocol and report preparation. Ensure products remain in a validated state through revalidation planning. Collaborate crossfunctionally with Quality, Operations, Engineering, and Development. Lead/support root cause investigations and drive remediation initiatives. Provide documentation and data for product transfers and launches. Travel 4070% to CMO locations across India and overseas for onsite support. Ensure compliance with regulatory and quality standards during transfers. Wruster coating experience will be considered an added advantage. Postgraduate in Pharmacy/Biotech/Life Sciences. Postgraduate in Pharmacy/Biotech/Life Sciences. 58 years of relevant MSAT/OSD technology transfer experience. Robust knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC). Proficiency in QbD, DoE, statistical analysis tools (e.g., Minitab) preferred. Excellent communication and crossfunctional collaboration skills. Fluent in English; regional language proficiency is an advantage. .