Technology Transfer Project Coordinator

At Adalvo, we are a team of passionate people driven by our mission to deliver high-quality products and services. We are positive, fast, and always on target.

We are looking for an enthusiastic Technical Transfer Project Manager to join our dynamic team. If you thrive in a fast-paced environment and love tackling new challenges, then this is the perfect opportunity for you.

This role will report directly to the Director, Project Management.

The primary responsibilities of this role include:

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. Facilitate problem-solving and decision-making with respect to project deliverables and meeting timelines/tasks/requests from project teams and other cross-functional departments.
4. Follow up with team members 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. Establish project plan baselines and document assumptions.
7. Fully understand business cases, including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors that may derail the project.
8. Prepare draft agendas, meeting minutes, presentations for project-related meetings to varied stakeholders, including governance boards.
9. May organize and participate in partner meetings as they relate to the position.
10. Review relevant project-specific documents.
11. Management of Reference Drug procurement and shipment - Compiles and monitors completion of key development tasks through milestone completion, quality gates, and stage gating processes.
12. Identify trends among common projects.
13. Identify project budget risks and opportunities, describe the impact, and adjust the budget to create acceleration opportunities for important milestones.
14. Manage and reports project budget, contract milestones, and spend according to established financial cycles.

Key qualifications and requirements include:

• 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.
• Should have thorough knowledge of generic drug development cycle including 505(B2), complex generics, peptides, various regulatory guidelines, and regulations.
• 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 required include:

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

Why choose 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.