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 standards of integrity and confidentiality while managing sensitive IP and regulatory information.
Partner with R&D/MSAT/Quality/RA for NPI and tech transfer: supplier onboarding, sample management, trial orders, and readiness for PPQ/validation activities (as applicable).
Qualifications
Master's degree in Synthetic Organic Chemistry, BE in Chemical Engineering,
M. Pharmacy, or a related discipline.
8+ years of experience in techno-commercial roles across pharma strategic sourcing, R&D Development, Technology Transfer, Vendor Management within regulated environments.
Working knowledge on Process Development of APIs and Regulatory documentation flows.
Strong capability in cost analysis, TCO modelling, and supplier/market assessment.
Proficiency in advanced Excel; experience with BI/analytics tools is a plus.
