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Data Driven Transformation Leader

3 weeks ago

Udaipur, Rajasthan, India beBeeProject Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Technical Transfer Project Manager

We're seeking a highly skilled and experienced Technical Transfer Project Manager to join our dynamic team. This role involves managing and coordinating technology transfer projects, tasks, schedules, status, and project reporting to stakeholders.

The ideal candidate will have a strong background in project management, preferably with experience in formulation development of solid oral dosage forms, parenteral dosage forms, liquid dosage forms, topical dosage forms, or nasal spray (protein and peptide delivery system/complex parenteral dosage forms).

In addition to project management skills, the successful candidate 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.).

The role requires excellent communication and problem-solving skills, with the ability to work independently and as part of a team. The ideal candidate will be self-driven, dynamic, and result-oriented, with a practical mindset.

Key Responsibilities:

  • Manage and coordinate technology transfer projects, tasks, schedules, status, and project reporting to stakeholders.
  • 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 report project budget, contract milestones, and spend according to established financial cycles.

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 forms, liquid dosage forms, topical dosage forms, or nasal spray (protein and peptide delivery system/complex parenteral dosage forms).('
  • 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 PowerPoint presentations.

CORE COMPETENCIES:

  • DYNAMIC
  • SELF-DRIVEN
  • CAPABLE TO WORK IN A HIGHLY ENTREPRENEURIAL ENVIRONMENT
  • RESULT-ORIENTED
  • PRACTICAL MINDSET

Why Join Us?

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.

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