Research Scientist - Tech Transfer
- GMP
Not enough detail in this posting to match
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Assist in the execution offormulation and process technology transfers from R&D to manufacturing sites (in-house and CMO).
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Conductscale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
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Support in thepreparation and review of Batch Manufacturing Records (BMRs) andvalidation protocols/reports.
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Coordinate withR&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
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Participate inprocess investigations, troubleshooting, and deviation handling during trial and validation batches.
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Assist inequipment selection andcapacity assessment based on product-specific requirements.
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Ensuredocument readiness for regulatory submissions, respond to technical queries, and support audit preparation.
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Supportinternal and external/vendor audits by providing required documentation and technical inputs.
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Contribute tocontinuous improvement initiatives and supportknowledge-sharing activities within the MSTG team.
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Preparedata summaries, technical reports, and presentations as per project or management requirements.
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Maintainaccurate records, follow applicableSOPs, and ensure strictGMP compliance in all operations.
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Qualifications
Qualifications & Skills
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B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology.
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2โ5 years of experience in formulation development, MS&T, or technology transfer.
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Exposure tosolid orals, liquids, or softgel capsule dosage forms.
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Understanding ofscale-up principles,equipment functionality, andvalidation practices.
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Familiar withregulatory expectations (USFDA, EU, etc.) andcGMP standards.
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Good communication, documentation, and teamwork skills.
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Willingness to travel to manufacturing sites as per project requirements.
Research Scientist - Tech Transfer ยท AVEVA DRUG DELIVERY SYSTEMS INC