Transfer Project Specialist

Job Overview

We are seeking a highly skilled Transfer Project Specialist to join our team. The ideal candidate will have a strong background in project management and experience with technology transfer projects.

Responsibilities:

• Project Coordination: Manage and coordinate technology transfer projects, tasks, schedules, status, and project reporting independently.
• Communication Facilitation: Facilitate communication within and outside the project team.
• Problem-Solving: Facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.
• Team Management: Follow up with team members to ensure timely deliverables (e.g., major milestones, cost, and scope).
• Risk Management: Focus on proactive planning to manage risk, remove barriers, and meet goals.
• Project Planning: Establish project plan baselines and document assumptions.
• Business Acumen: Fully understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape, and other potential external factors that may derail the project.
• Meeting Preparation: Prepare draft agendas, meeting minutes, presentations for project-related meetings to varied stakeholders, including governance boards.
• Partner Engagement: May organize and participate in partner meetings as they relate to the position.
• Document Review: Review relevant project-specific documents.
• Reference Drug Procurement: Management of Reference Drug procurement and shipment - Compiles and monitors completion of key development tasks through milestone completion, quality gates, and stage gating processes.
• Trend Analysis: Identify trends among common projects.
• Financial Management: Identify project budget risks and opportunities, describe the impact, and adjust the budget to create acceleration opportunities for important milestones.
• Travel: Ready to travel different CMDO/CMO/CPO across different geographies as per organizational need.

Requirements & Qualifications:

• 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).
• Knowledge: 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.).
• EPM Software Expertise: Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
• Technical Skills: Should have knowledge of EPM / MSP software and expert in Microsoft excel and power point presentations.

Core Competencies:

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

Why Work with 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.