Senior Technical Project Lead

This is an exciting opportunity for a highly skilled and experienced Technical Transfer Project Manager to join our organization. In this role, you will be responsible for managing and coordinating Technology Transfer projects from inception to completion.

The ideal candidate will have a strong background in project management, with experience in managing complex projects involving multiple stakeholders and teams. They will also possess excellent communication and interpersonal skills, with the ability to facilitate effective collaboration and problem-solving among team members.

The successful candidate will be able to work independently and as part of a team, with a focus on delivering high-quality results within tight deadlines. They will also be proactive in identifying and mitigating risks, and will have a thorough understanding of business operations and regulatory requirements.

• Key Responsibilities:
• Manage and coordinate Technology Transfer projects, tasks, schedules, status, and project reporting to stakeholders independently.
• 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. shall be involved in 5YP budget preparation, 3+9, 6+6, and 9+3 forecast preparation.
• Ready to travel different CMDO/CMO/CPO across different geographies as per organizational need.

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 form, Liquid dosage form, Topical dosage form, Nasal spray (Protein and Peptide Delivery System/Complex Parenteral Dosage forms will be added advantage).
• 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 power point 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.

Are You Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you Send us your resume today

Please be informed that only selected candidates will be contacted.