Formulation Development Manager

2 weeks ago

Lucknow, Uttar Pradesh, India beBeeProjectManagement Full time ₹ 35,00,000 - ₹ 60,00,000
Project Management Professional

  • Manage and coordinate technology projects, tasks, schedules, status, and project reporting to stakeholders independently.
  • Facilitate communication within and outside the project team.
  • Problem-solve and make decisions regarding project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.
  • Follow up with team members to ensure timely deliverables (e.g., major milestones).
  • Focus on proactive planning to manage risk, remove barriers, and meet goals.
  • Establish project plan baselines and document assumptions.
  • Understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors which may impact the project.
  • Prepare draft agendas, meeting minutes, presentations for project-related meetings to varied stakeholders.
  • Organize and participate in partner meetings as they relate to the position.
  • Review relevant project-specific documents.
  • Manage Reference Drug procurement and shipment - Compile 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 report project budget, contract milestones, and spend according to established financial cycles.
  • Ready to travel across different geographies as per organizational need.

Qualifications & Requirements

  • Qualification: Master's degree in Pharmacy or Bachelor's degree in Pharmacy with a Master's degree in Business Administration.
  • 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.
  • 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.
  • Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM.
  • Should have knowledge of EPM/MSP software and be expert in Microsoft Excel and PowerPoint presentations.

CORE COMPETENCIES

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

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