Research Scientist - Tech Transfer
Summary
A research scientist focused on technology transfer and scale-up activities in drug delivery systems, ensuring validated processes, technical support for CMOs, and compliance with regulatory standards. Core work involves process optimization, documentation review, and cross-functional collaboration with travel required for on-site support.
- 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.