- Lead Commercial batch manufacturing and technology Transfer activities to internal and external (CMO) manufacturing sites for solid orals, liquids, softgel, parenteral and semisolid dosage forms.
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Drive CMO selection based on technical capabilities, capacity, regulatory compliance, and project feasibility.
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Plan and execute site readiness, including audit preparation, gap assessment, and technical capability mapping.
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Review and finalize regulatory submission documents (Module 3 – CMC) and provide timely responses to agency queries in coordination with Regulatory Affairs.
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Define and oversee batch execution strategy, including scale-up, validation and commercial batches.
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Monitor and guide the preparation and review of key documents including CBMRs, validation protocols, and technical reports.
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Coordinate with cross-functional stakeholders –Project Management, R&D, QA, QC, Regulatory, SCM, and Manufacturing – for seamless knowledge transfer and project execution.
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Act as a single point of contact for technical discussions with internal teams and CMOs.
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Identify and resolve process challenges during scale-up and commercial execution, ensuring timely issue resolution and continuous supply as per market forecast.
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Support regulatory inspections, customer audits, and internal quality audits at CMO or in-house facilities.
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Mentor and supervise team members to build functional expertise and ensure high performance.
M. Pharma with around 15-17 years of expertise in execution of commercial batch manufacturing, with regulatory compliance
