Research Scientist - Tech Transfer en AVEVA DRUG DELIVERY SYSTEMS INC

Description

• Assist in the execution of formulation and process technology transfers from R&D to manufacturing sites (in-house and CMO).

• Conduct scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.

• Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.

• Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.

• Participate in process investigations, troubleshooting, and deviation handling during trial and validation batches.

• Assist in equipment selection and capacity assessment based on product-specific requirements.

• Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.

• Support internal and external/vendor audits by providing required documentation and technical inputs.

• Contribute to continuous improvement initiatives and support knowledge-sharing activities within the MSTG team.

• Prepare data summaries, technical reports, and presentations as per project or management requirements.

• Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.

Qualifications

Qualifications & Skills

• B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology.

• 2–5 years of experience in formulation development, MS&T, or technology transfer.

• Exposure to solid orals, liquids, or softgel capsule dosage forms.

• Understanding of scale-up principles, equipment functionality, and validation practices.

• Familiar with regulatory expectations (USFDA, EU, etc.) and cGMP standards.

• Good communication, documentation, and teamwork skills.

• Willingness to travel to manufacturing sites as per project requirements.