
Project Management
4 days ago
Job Details Role
BD OSD Out licensing - Global Contract Manufacturing
LocationZydus Corporate Park, Ahmedabad
Experience4-7 years
QualificationB. Pharm / Mpharm with MBA.
SummaryNew product identification, analysis and evaluation of the products with respect to business potential in terms of technical gap analysis, therapy, market share etc. for OSD, CDMO/CMO for complex injectables projects for regulated markets (EU, Japan). Focus on strong analytical skills for Oncology therapy product identification & portfolio management, project management of awarded projects for development to launch as Alliance Management member. Accountable for proactively managing successful execution of product development stage gate, creating WBS and project updates.
Key Stakeholders- R&D
- BD
- Alliance Management
- Supply Chain Leads
- Development of portfolio for out-licensing/key assets identification of oral solids, injectables including market environment desk research.
- Alliance management of OL clients, project management of CDMO and CMO projects with regular interaction with clients.
- Identification of potential products for out-licensing, CDMO and desk research on potential NDA, 505B2 assets.
- Business case & scenario development for potential business deals.
- To develop/identify product portfolio for out-licensing and data analytics.
- Point of contact from client side with internal stakeholders on deliverables & maintain and update the client on project milestones/progress. Participate in COE, launch readiness meeting and get updated on the project status.
- To lead the project management calls with client along with internal stakeholders (point of contact).
- To project manage with CFT the technical documentation review, launch update, facilitate regulatory audits, face-to-face meetings /weekly telecom, minutes etc. on behalf of client. Regular follow-up/update on annual forecasts, pending orders, maintaining MIS etc.
- To develop scenarios/business cases for potential out-licensing deals, undertake market research on potential molecules, work with legal team on CDA, OL agreement, project plans and commercial delivery updates.
- Minimum 4-6 years of experience with at least 5-9 years in BD & portfolio management or BD & portfolio management and preferably should have handled client serving projects for regulated markets.
- Must have handled regulated formulation plants/markets projects and injectables dosage forms.
- Basic knowledge of legal agreements (commercial & supply, quality & technical, MSA, CDA) and working as per contractual obligations.
- Caliber of undergoing competitive intelligence and market research would be preferred.
- Managing cross-functional team & understands project management process & milestones for US, Europe development and site transfer projects.
- Comprehends the importance of process and should be excellent at written & verbal communication.
- Must have sound knowledge of MS Office (Word, Excel & PPT).
- Possess good presentation skills, data representation, IMS evaluation, SAP.
- Go-getter. Proactive & ready to accept the challenges.
Manufacturing-formulation | , Ahmedabad, Gujarat, India
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