Research Scientist - Tech Transfer

Job Title: Research Associate – MSAT (Technology Transfer), OSD

Key Responsibilities:

  • 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.