
Technology Transfer Project Coordinator
5 days ago
We seek a skilled and experienced Project Manager to oversee Technology Transfer projects, ensuring timely deliverables and effective communication with stakeholders.
The successful candidate will be responsible for managing project schedules, status, and reporting, as well as facilitating problem-solving and decision-making within the project team.
- Coordinate Technology Transfer projects, tasks, and schedules to meet project goals and stakeholder expectations.
- Facilitate communication and collaboration among project team members, including coordination of meetings and preparation of meeting materials.
- Identify and mitigate potential risks and barriers to project success, developing proactive plans to address these challenges.
- Monitor and report on project progress, providing regular updates to stakeholders.
The ideal candidate will have a strong background in project management, with experience in technology transfer and a thorough understanding of regulatory guidelines.
They will also possess excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.
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 an advantage).
- 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.).
- Thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM, etc.
- Knowledge of EPM/MSP software and expert in Microsoft Excel and PowerPoint presentations.
Benefits: The opportunity to work in a dynamic and entrepreneurial environment, with a focus on delivering high-quality products and services.
Core Competencies:- Dynamic
- Self-Driven
- Capable to work in a highly entrepreneurial environment
- Result-oriented
- Practical mindset
Additional Requirements: Willingness to travel as needed to support project objectives.
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