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.

- Postgraduate in Pharmacy/Biotech/Life Sciences.
- 2–6 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 cross‑functional collaboration skills.
- Fluent in English; regional language proficiency is an advantage.

📌 Research Scientist - Tech Transfer (India)
🏢 DIFGEN PHARMACEUTICALS PRIVATE
📍 India