Senior Technical Operations Specialist

We are seeking a skilled Technical Transfer Project Manager to join our team.

• This role will be responsible for managing and coordinating Technology Transfer projects, tasks, schedules, status and project reporting to stakeholders independently.

• 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 monitor 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
• Ready to travel different CMDO/CMO/CPO across different geographies as per organizational need

• 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

• Exciting Challenges: Every day brings new opportunities to learn and grow
• Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard
• Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities
• Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements
• Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team