VP, Site Head, Toulouse Operations

Vice President, Site Head, Toulouse Operations The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at Just-Evotec Biologics state of the art J.POD Facility located in Toulouse, France. This role will partner with Global MSAT, Quality Assurance, Facilities & Engineering, Materials Management, and EH&S functions to ensure plant-readiness and ongoing operational success. The initial job duties will be to manage all operational readiness activities, including multiple cross-functional workstreams. The primary goal is to complete the validation of the J.POD Facility and associated production/quality systems; ensuring that these are suitable for commercial manufacturing, compliant, inspection ready, and licensable by ANSM, US FDA and EMA health authorities. Additional job responsibilities will include: Manage site performance, ensuring operational excellence (OE) Execute hiring strategy and implement high performing team. Establish and maintain platform approaches for standardized work, partner with Quality to establish GMP and OE training programs. Support electronic systems infrastructure. Provide oversight of materials inventory management and control. Review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements. Successful execution of advanced biologics manufacturing technologies. Troubleshooting and/or providing technical expertise to perform, lead, and close investigations. Assist in the generation of relevant regulatory submissions. Implementation and/or maintenance of cGMP compliant systems. Provide support for regulatory and site inspections. Manage OPEX and CAPEX budgets for site operational functions. Develop a culture of continuous improvement. Incorporate and expand sustainability into manufacturing operations. Build and develop staff for future roles and career progression; and ensure a culture of safety. POSITION REQUIREMENTS Excellent interpersonal skills to develop strong collaborations across functions, sites, and leadership levels. Excellent oral and written communication skills to align and inspire teams to achieve company objectives. Candidate must possess a strong focus on quality and attention to detail. Establish high performing teams to accelerate new technology development with a focus on first in class therapeutics. 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. Commissioning, qualification, and validation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports. Strong understanding of process automation (e.g., DeltaV) and validated BAS systems Experienced in the use of electronic systems such as QMS, LIMS, MES/EBR, CMMS, and ERP systems. Previous experience managing the activities of individuals, work groups, and project teams. Possess effective task/time management organizational skills. Motivated, self-starter with strong mechanical aptitude Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project) ADDITIONAL PREFERRED QUALIFICATIONS Fluent in both English and French languages (oral and written) Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines. Biotherapeutics cGMP manufacturing experience In-depth knowledge of equipment, operations, and engineering principles Experienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus. Development, scale-up, and transfer of biologics production processes Knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technological advancement. Active participation/lead technical projects with collaborators and vendors This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally. #J-18808-Ljbffr