Head of Manufacturing Operations
il y a 6 jours
We are seeking a highly experienced and skilled Vice President, Head of Manufacturing Operations to lead our late-stage clinical and commercial biologics manufacturing operations at our state-of-the-art J.POD facility in Toulouse, France.
Key Responsibilities- Manage plant performance and ensure operational excellence
- Establish a high-performing team and implement strategies for accelerated technology platform implementation
- Develop and maintain platform approaches for standardized work and partner with Quality to establish GMP and OE training programs
- Establish and model a culture of compliance and review/approve GMP controlled documentation
- Ensure successful execution of advanced biologics manufacturing technologies and troubleshoot technical issues
- Implement and maintain cGMP compliant systems and provide support for regulatory and site inspections
- Develop a culture of compliance, continuous improvement, and safety, and incorporate sustainability into manufacturing operations
- Build and develop staff for future roles and career progression
- Extensive experience in late-stage/commercial biologics drug substance manufacturing
- Technical mastery of cell culture and purification operations at commercial scale
- Proven knowledge of cGMP requirements and advanced skills in single-use technologies
- Experience in commissioning, qualification, and validation, including risk assessments and process automation
- Strong understanding of electronic systems and previous experience managing individuals, work groups, and project teams
- Exceptional interpersonal, team, and communication skills, and strong computer skills
- Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines
- Commercial cGMP manufacturing experience and in-depth knowledge of equipment, operations, and engineering principles
- Experience in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns
- Knowledge and expertise to solve complex technical problems and apply novel approaches
Evotec is an equal opportunities employer and welcomes applications from all qualified candidates, including those with disabilities.
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Head of Manufacturing Operations
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