Senior Manager, Technology Transfer

4 days ago


Erode, Tamil Nadu, India beBeeProject Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Technical Project Manager

This role involves managing technology transfer projects, tasks, schedules, status, and project reporting to stakeholders independently.

The ideal candidate will be able to facilitate communication within and outside the project team, as well as facilitate problem-solving and decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.

Responsibilities include:

  • Managing Technology Transfer projects, tasks, schedules, status, and project reporting to stakeholders independently.
  • Facilitating communication within and outside the project team.
  • Facilitating problem-solving and decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.
  • Following up with team members to ensure timely deliverables (e.g., major milestones, cost, and scope).
  • Focusing on proactive planning to manage risk, remove barriers, and meet goals.
  • Establishing project plan baselines and documenting assumptions.
  • Fully understanding business cases including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors that may derail the project.
  • Preparing draft agendas, meeting minutes, presentations for project-related meetings to varied stakeholders, including governance boards.
  • Reviewing relevant project-specific documents.
  • Managing Reference Drug procurement and shipment - compiling and monitoring completion of key development tasks through milestone completion, quality gates, and stage gating processes.
  • Identifying trends among common projects.

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)
  • 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.)
  • Thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
  • EPM / MSP software expertise and Microsoft excel and power point presentation skills.

CORE COMPETENCIES

  • DYNAMIC
  • SELF-DRIVEN
  • Capable to work in a highly entrepreneurial environment
  • RESULT ORIENTED
  • PRACTICAL MINDSET


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