Manager

Designation: Manager - Project Management Office Location: Andheri, Mumbai Position description: Primarily responsible for project managing generic / complex generic R&D projects that are in-licensed, co-developed & tech-transferred to CMO’s, manage new product launches and alliances for US market. Primary Responsibilities Primarily a techno-commercial role for project managing generic / complex generic projects for US market. Lead techno-commercial evaluation of new product opportunities, technology platforms, CDMO’s, CRO’s. Provide technical inputs on drug development, CMC, non-clinical & clinical aspects for complex generic products –: in-house & licensed (in/out). Understand, communicate and provide perspective on the views of external experts / regulatory agencies, relevant to the project’s development strategy - highlight risks and risk mitigation strategies. Define, establish & implement the Project Management process for the said portfolio; establish Project review mechanisms & conduct of project within approved budgets – ensure successful completion of project milestones as per project plans. Project manage CMO & tech-transfer projects – T echno-commercial evaluation of CMO/CDMO/CRO; Preparing RFP, Contracting, Project execution & tracking. Manage new product launches for partnered products – Provide end to end visibility of launch plans to all stakeholders and ensure timely execution of plans. Alliance management of IL/CDMO partners. Educational Qualifications Minimum of a Bachelor Degree in Pharma/ Biotech preferably with an MBA. PMP certification is an added advantage. Required work experience Must possess experience of 10 - 12 years in R&D / Regulatory related roles with good exposure to technology, product assessments, commercial aspects, etc. Must have exposure to US/EU Regulatory environment, experience in complex technology platforms (NDDS) will be an advantage. Exposure to BD and/or Alliance management would be an added advantage. Key Interfaces External Licensing partners, CMO/CDMO, Consultants, Design houses, Contract Manufacturers, Regulatory Consultants, Clinical Consultants. Internal R&D, Regulatory affairs, Clinical Services, QA, BD & Portfolio team. Required Knowledge & Skills: Understanding of drug development across R&D/ Manufacturing/ Clinical aspects . Good analytical & communication skills. Project Management tools & Techniques.