Adalvo is looking for a Project Manager to join our dynamic team in India.
- Managing and coordinating projects, tasks, schedules, status and project reporting to stakeholders, independently
- Managing contract development and manufacturing, providing technical support as per requirement along with PM Lead
- Ready to travel different CMDO/CMO/CPO across different geographies as per organizational need
- identifying critical path delays in project and highlight risks associated with project to PM Lead
- Focusing on proactive planning to manage risk, remove barriers and meet goals
- Managing day-to-day project communication with project team and develop and maintain positive working relationships
- Preparing project documentation including meeting agendas, meeting minutes, monthly reports, meeting follow-ups, manage project-related templates and any other identified communication documentation deemed necessary by the PM – Lead
- Should have fair understanding of project budget, contract milestones and spend according to established financial cycles
QUALIFICATIONS, EXPERIENCE & REQUIREMENTS
- Experience: At least 5 years of experience in Project Management with prior experience in Formulation Development of Protein and Peptide Delivery System/Complex Parenteral Development
- Qualification: M. Pharmacy or B. Pharmacy with MBA.
- Should have thorough knowledge of generic drug development cycle including 505(B2) projects, complex Injectable dosage forms, various regulatory guidelines, (ICH, GMP, GCP etc.) and submission process.
- Preferably, hands on experience and in-depth understanding of chemical approaches such as PEGylation, hyperglycosylation, mannosylation, and colloidal carriers including microparticles, nanoparticles, liposomes, carbon nanotubes and micelles related to protein and peptide delivery.
- Thorough understanding of various development pathways and regulatory filing approaches of protein and peptide-based delivery.
- Should have knowledge of EPM / MSP software and expert in Microsoft excel