Senior Technology Integration Specialist

We are seeking a highly skilled Technical Transfer Project Manager to lead the coordination and management of technology transfer projects from development through commercialization.

This role will report directly to the Director, Project Management and is located in India. The ideal candidate will have a strong background in project management, with experience in managing cross-functional teams and ensuring timely delivery of projects.

• Main Responsibilities:
• Manage and coordinate Technology Transfer projects, tasks, schedules, status, and project reporting to stakeholders independently
• Facilitate communication within and outside the project team
• Facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments
• Follows up with team members to ensure timely deliverables (e.g., major milestones, cost, and scope)
• Focus on proactive planning to manage risk, remove barriers, and meet goals
• Establish project plan baselines and document assumptions
• Fully understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors which may derail the project
• Prepare draft agendas, meeting minutes, presentations for project-related meetings to varied stakeholders, including governance boards
• May organize and participate in partner meetings as they relate to the position
• Review relevant project-specific documents
• Management of Reference Drug procurement and shipment - Compiles and monitors completion of key development tasks through milestone completion, quality gates, and stage gating processes
• Identify trends among common projects
• Identify project budget risks and opportunities, describe the impact, and adjust the budget to create acceleration opportunities for important milestones
• Manage and reports project budget, contract milestones, and spend according to established financial cycles. Shall be involved in 5YP budget preparation, 3+9, 6+6, and 9+3 forecast preparation
• Ready to travel different CMDO/CMO/CPO across different geographies as per organizational need

Qualifications & Requirements:

• Qualification: M. Pharmacy or B. Pharmacy with MBA
• Experience: At least 9 years of experience in Project Management with prior experience in Formulation Development of solid oral dosage forms, Parenteral dosage form, Liquid dosage form, Topical dosage form, Nasal spray (Protein and Peptide Delivery System/Complex Parenteral Dosage forms will be added advantage)
• Should have thorough knowledge of generic drug development cycle including 505(B2), complex generics, peptides, various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.)
• Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
• Should have knowledge of EPM / MSP software and expert in Microsoft excel and power point presentations

Core Competencies:

• Dynamic
• Self-Driven
• Capable to work in a highly entrepreneurial environment
• Result-oriented
• Practical mindset

Benefits:

We offer an exciting opportunity to join a dynamic organization and contribute to the success of our projects. Our employees enjoy a supportive environment, career growth opportunities, and recognition of their achievements.

We believe in celebrating our successes and building strong connections within our team. If you're ready to take the next step in your career and join a business committed to delivering high-quality products and services, we want to hear from you.