Senior Vice President of Biologics Manufacturing
il y a 3 semaines
Location: Toulouse
Time Type: Full time
Job Requisition ID: JOB ID-10797
The primary responsibility of this role is to oversee and direct the advanced stages of clinical and commercial biologics production operations (including Cell Culture, Purification, and Support Services) at Evotec WD's cutting-edge manufacturing facility. This position will collaborate with various departments such as MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and EH&S to ensure operational readiness and sustained success.
The initial responsibilities will include recruiting and establishing the manufacturing team while leading readiness initiatives to support commercial GMP production. Furthermore, the Senior Vice President will manage all GMP production activities, ensuring that the facility is compliant, prepared for inspections, and meets the licensing requirements of regulatory authorities.
Key Responsibilities:
- Oversee plant performance, ensuring operational excellence (OE)
- Develop hiring strategies and implement high-performance team tactics to expedite new technology platform integration, focusing on the production of innovative therapeutics
- Create and uphold standardized work processes; collaborate with Quality to develop GMP and OE training programs
- Foster and exemplify a culture of compliance
- Review and authorize GMP-controlled documentation, ensuring adherence to technical and regulatory standards
- Ensure the successful implementation of advanced biologics manufacturing technologies
- Provide troubleshooting and technical expertise to lead and resolve investigations
- Implement and maintain cGMP compliant systems
- Support regulatory and site inspections
- Cultivate a culture of compliance, continuous improvement, and safety
- Integrate and enhance sustainability within manufacturing operations
- Build and mentor staff for future roles and career advancement while promoting a culture of safety
Additional Requirements:
- Extensive experience in late-stage/commercial biologics drug substance manufacturing
- Technical expertise in cell culture and purification operations at a commercial scale
- Proven knowledge of cGMP regulations to ensure compliance
- Advanced skills in operating single-use technologies, including cell culture, purification, and drug substance filling operations
- Experience in commissioning, qualification, and validation processes, including risk assessments and qualification reports
- Proficient in facilitating risk assessments, including single point of failure (SPOF) and failure modes & effects (FMEA)
- Strong understanding of process automation and validated BAS systems
- Familiarity with electronic systems such as QMS, LIMS, MES/EBR, CMMS, and ERP systems
- Active participation in leading technical projects with collaborators and vendors
- Previous experience managing teams and project groups
- Strong focus on quality and meticulous attention to detail
- Effective task/time management and strong organizational skills
- Motivated self-starter with strong mechanical aptitude
- Exceptional interpersonal, team, and communication skills required
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, and MS Project)
Additional Preferred Qualifications:
- Comprehensive knowledge of US FDA CFRs and European EMA regulations, including ICH guidelines
- Experience in commercial cGMP manufacturing
- In-depth understanding 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 resolve complex technical challenges; ability to apply innovative approaches for significant technological advancements
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