Job Details: Job Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA, Salary Range: Undisclosed, Job Shift: Day, 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.