Cmc Project Leader
vor 1 Woche
You will also take charge if strategic direction and the oversight of global and local cross-functional CMC teams across a number of areas, in order to define and deliver contemporary CMC packages across life cycle management, market authorisation and clinical development. Your expertise in biologics and process validation will be crucial in maintaining high-quality standards and regulatory compliance.
**Responsibilities**:
- Lead and manage the process validation activities for the development and manufacturing of biopharmaceutical products
- Deliver and define contemporary CMC packages during clinical development, market authorisation and life cycle management
- Develop and execute process validation protocols, ensuring compliance with regulatory requirements and industry best practices
- Collaborate closely with cross-functional teams, including process development, manufacturing, quality assurance, regulatory affairs, and analytical sciences, to ensure alignment and timely execution of validation strategies
- Provide technical expertise and guidance on process validation, including risk assessments, statistical analysis, and validation documentation
**Qualifications**
- Bachelor's or advanced degree in a scientific or engineering discipline is required. A higher degree (e.g., Master's or Ph.D.) is preferred
- Extensive experience in manufacturing operations, process design and process validation, particularly within the biopharmaceutical or biotechnology industry
- In-depth understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) related to process validation, cleaning validation, and QbD.
- Demonstrated expertise in managing and leading cross-functional teams in a matrixed organization, with excellent project management and communication skills
**Job Type**: Fixed term
Work Location: Remote
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