, and new dosage forms.
Plan, execute, and monitor development activities from concept to scale-up and technology transfer.
Ensure compliance with regulatory, cGMP, and quality requirements for sterile and nutra products.
Oversee product feasibility, pre-formulation studies, stability studies, and process optimization.
Collaborate with Production, QA, QC, RA, and Purchase for smooth project execution.
Prepare and review technical documents: MFR, BMR, PDR, validation protocols, development reports.
Manage vendor coordination for raw materials, excipients, and packaging components.
Lead troubleshooting during pilot, exhibit batches, and commercial scale-up.
Guide and mentor the F&D team, ensuring timely completion of R&D projects.
Support regulatory filings and respond to technical queries.
Requirements:
M.Pharm / M.Sc. with strong experience in sterile formulations & nutraceutical development.
Proven expertise in injectable manufacturing processes, lyophilization (if applicable), and formulation techniques.
Strong documentation, project management, and team-handling skills.
Knowledge of regulatory guidelines (US/EU/ROW) preferred.
Job Type: Permanent
Benefits:
Provident Fund
Work Location: In person
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