cmo/cdmo
1 week ago
Role & responsibilities
- Identify, evaluate, and onboard global CDMO partners for formulation development, API sourcing, and finished dosage manufacturing.
- Negotiate and manage contracts, SLAs, and quality agreements with external manufacturing partners.
- Identify clients for tie-ups for identified, under-execution and executed C/DMO projects for Out-licensing.
- Responsible for managing the entire CMO & CDMO service business sale cycle including identification and qualification of leads, proposal generation, and contract negotiation.
- Will be overall responsible for revenue and profitability targets for allocated territories including all CMO/ CDMO customers
- Identify, evaluate, negotiate, execute and commercialize final products with respective GMP approved CMO sites.
- Identify and acquire product portfolio for extension into CMO manufacturing.
- Conduct due diligence on product dossiers, IP status, regulatory pathways, and commercial viability.
- Handle CMO/ CDMO business for existing clients for regulated, Semi regulated and India market.
- Would be responsible for designing and finalizing legal contracts for out- licensing and CMO/CDMO
- Ensure regulatory compliance across US FDA, EMA, MHRA, and other global authorities for outsourced products.
- Collaborate with internal teams (QA, RA, Supply Chain) to ensure seamless tech transfer and commercial readiness.
- Lead deal structuring, term sheet negotiations, and alliance management post-signing.
- Monitor global trends in outsourcing, regulatory shifts, and therapeutic demand to inform portfolio decisions.
- Represent the company at international conferences, partnering forums, and regulatory roundtables.
- Maintain competitive intelligence on peer CDMO capabilities, pricing benchmarks, and licensing activity.
Preferred candidate profile
12+ years of relevant experience in pharmaceutical CMO/CDMO management, business development, or licensing.
Proven track record of managing global partnerships and navigating regulatory frameworks (US FDA, EMA, TGA, etc.).
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