Job Description
Key Responsibilities
- Lead techno-commercial evaluations: review process routes, specs/CoA requirements, analytical methods, and manufacturing capabilities;
assess scale-up/tech transfer readiness and risks. - Coordinate with CMC/Regulatory Affairs and Quality to collect and review supplier documentation to support VQ, Vendor audits and Regulatory Filings (e.G., DMF/ASMF support packs), and compliance expectations.
- Develop and maintain should-cost models, clean sheets, and cost breakdowns for pharma manufacturing processes (including solvent/raw-material indexing) to support fact-based negotiations.
- Evaluate, and onboard new suppliers/alternate vendor;
manage vendor performance based on technical capability, quality, Compliance, and cost metrics. - Conduct market intelligence to identify cost effective manufacturing processes and technical evaluation for feasibility and onboarding.
- Ensure high ...