Research Scientist - Tech Transfer

• Provide technical support to internal sites and CMOs, ensuring validated processes.
• Act as technical expert during technology transfer and scale‑up activities.
• Apply science‑ and risk‑based 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 scale‑up 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 cross‑functionally 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 40–70% to CMO locations across India and overseas for on‑site support.
• Ensure compliance with regulatory and quality standards during transfers.
• Wruster coating experience will be considered an added advantage.

Qualifications

• Postgraduate in Pharmacy/Biotech/Life Sciences.
• Postgraduate in Pharmacy/Biotech/Life Sciences.
• 5–8 years of relevant MSAT/OSD technology transfer experience.
• Strong knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC).
• Proficiency in QbD, DoE, statistical analysis tools (e.g., Minitab) preferred.
• Excellent communication and cross‑functional collaboration skills.
• Fluent in English; regional language proficiency is an advantage.