Expert Project Leadership

We are seeking a skilled Technical Transfer Project Manager to lead and manage Technology Transfer projects from initiation through completion.

The successful candidate will coordinate project tasks, schedules, status, and project reporting to stakeholders while facilitating communication within and outside the project team. Additionally, this role involves problem-solving, decision-making, and ensuring timely deliverables.

1. Manage and coordinate Technology Transfer projects, tasks, schedules, status, and project reporting to stakeholders independently.
2. Facilitate communication within and outside the project team.
3. Resolve issues with respect to project deliverables and meeting timelines/tasks/requested by project teams and other cross-functional departments.
4. Track team members' progress to ensure timely deliverables (e.g., major milestones, cost, and scope).
5. Focus on proactive planning to manage risk, remove barriers, and meet goals.
6. Develop project plan baselines and document assumptions.
7. Understand business cases, including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors that may impact the project.
8. Prepare agendas, minutes, presentations for project-related meetings to varied stakeholders, including governance boards.
9. Organize and participate in partner meetings as they relate to the position.
10. Review relevant project-specific documents.
11. Oversee Reference Drug procurement and shipment – compile and monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes.
12. Identify trends among common projects.
13. Assess project budget risks and opportunities, describe the impact, and adjust the budget to create acceleration opportunities for important milestones.
14. Manage and report project budget, contract milestones, and spend according to established financial cycles.

1. Qualification: M. Pharmacy or B. Pharmacy with MBA.
2. 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).
3. 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.).
4. Thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
5. Proficiency in EPM/MSP software and expert in Microsoft Excel and PowerPoint 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.

This Technical Transfer Project Manager role offers a dynamic and challenging opportunity to join a progressive organization. As a key member of our team, you will have the chance to develop your skills and expertise while making a significant contribution to our success.

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.