Job Title: Research Associate – MSAT (Technology Transfer), OSD
Key Responsibilities:
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Provide technical support to internal sites and CMOs, ensuring validated processes.
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Act as technical expert during technology transfer and scale‑up activities.
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Apply science‑ and risk‑based approaches to maintain sustainable product quality.
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Review and approve technical documentation (BMRs, Process Validation protocols/reports, Stability protocols/reports, risk assessments, validation documents, RA documents) for timely submission.
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Execute and monitor batches, applying scale‑up factors for process optimization.
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Maintain oversight of CQAs, CMAs, and CPPs to ensure process robustness.
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Support validation strategies, including protocol and report preparation.
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Ensure products remain in a validated state through revalidation planning.
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Collaborate cross‑functionally with Quality, Operations, Engineering, and Development.
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Lead/support root cause investigations and drive remediation initiatives.
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Provide documentation and data for product transfers and launches.
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Travel 40–70% to CMO locations across India and overseas for on‑site support.
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Ensure compliance with regulatory and quality standards during transfers.
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Wruster coating experience will be considered an added advantage.
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Postgraduate in Pharmacy/Biotech/Life Sciences.
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2–6 years of relevant MSAT/OSD technology transfer experience.
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Strong knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC).
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Proficiency in QbD, DoE, statistical analysis tools (e.g., Minitab) preferred.
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Excellent communication and cross‑functional collaboration skills.
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Fluent in English; regional language proficiency is an advantage.
