Head of Biologics Manufacturing Operations

il y a 3 semaines


Toulouse, Occitanie, France Evotec WD Temps plein
Job Summary

We are seeking a highly experienced and skilled professional 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 to ensure operational excellence
  • Establish and implement high-performing team tactics to accelerate new technology platform implementation
  • Establish and maintain platform approaches for standardized work, partnering with Quality to establish GMP and OE training programs
  • Establish and model a culture of compliance, reviewing and approving GMP controlled documentation to ensure technical and regulatory requirements are met
  • Ensure successful execution of advanced biologics manufacturing technologies, troubleshooting and providing technical expertise as needed
  • Implement and maintain cGMP compliant systems, providing support for regulatory and site inspections
  • Develop a culture of compliance, continuous improvement, and safety, incorporating and expanding sustainability into manufacturing operations
  • Build and develop staff for future roles and career progression, ensuring a culture of safety
Requirements
  • 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 to ensure compliance
  • Advanced skills in the operation of single-use technologies, including cell culture, purification, and drug substance filling operations
  • Experience in commissioning, qualification, and validation, including risk assessments and electronic systems
  • Strong understanding of process automation and validated BAS systems
  • Previous experience managing the activities of individuals, work groups, and project teams
  • Strong focus on quality and attention to detail, with effective task/time management and organizational skills
  • Motivated, self-starter with strong mechanical aptitude and exceptional interpersonal, team, and communication skills
Preferred Qualifications
  • Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines
  • Commercial cGMP manufacturing experience
  • 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, applying novel approaches to provide significant technology advancement


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