Vice President, Head of Manufacturing Operations - all genders

Vice President, Head of Manufacturing Operations - all gendersThe 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 position will partner with MSAT, Quality Assurance, Facilities and Engineering, PMO, OE and EH&S functions to ensure plant readiness and ongoing operational success.The initial job duties will be to recruit and build the manufacturing organization, while leading operational readiness activities to support commercial GMP manufacturing. Additionally, the Head of Manufacturing Operations will oversee all GMP manufacturing operations while ensuring the manufacturing plant is commercially compliant, inspection ready, and licensable by the US FDA and EMA health authorities.Job responsibilities:Manage plant performance, ensuring operational excellence (OE)Establish the hiring strategy and implement high performing team tactics to accelerate new technology platform implementation with a focus on manufacture of first-in-class therapeuticsEstablish and maintain platform approaches for standardized work; partner with Quality to establish GMP and OE training programsEstablish and model a culture of complianceReview and approve GMP controlled documentation, ensuring that it meets technical and regulatory requirementsEnsure successful execution of advanced biologics manufacturing technologiesTroubleshoot and/or provide technical expertise to perform, lead, and close investigationsImplement and/or maintain cGMP compliant systemsProvide support for regulatory and site inspectionsDevelop a culture of compliance, continuous improvement and safety.Incorporate and expand sustainability into manufacturing operationsBuild and develop staff for future roles and career progression; and ensure a culture of safetyAdditional requirements:Extensive experience in late stage/commercial biologics drug substance manufacturingTechnical mastery of cell culture and purification operations at commercial scaleProven knowledge of cGMP requirements to ensure complianceAdvanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operationsExperience in commissioning, qualification, and validation, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reportsExperienced risk assessment facilitator, including single point of failure (SPOF) and failure modes & effects (FMEA)Strong understanding of process automation (e.g., DeltaV) and validated BAS systemsExperienced in the use of electronic systems such as QMS, LIMS, MES/EBR, CMMS, and ERP systemsActive participation/lead technical projects with collaborators and vendorsPrevious experience managing the activities of individuals, work groups, and project teamsStrong focus on quality and attention to detailPossess effective task/time management and strong organizational skillsMotivated, self-starter with strong mechanical aptitudeExceptional interpersonal, team, and communication skills requiredStrong computer skills including Microsoft Office (Word, Excel, Power Point, and MS Project)Additional preferred qualifications:Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelinesCommercial cGMP manufacturing experienceIn-depth knowledge of equipment, operations, and engineering principlesExperience in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plusExperience in the development, scale-up, and transfer of biologics production processesKnowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancementFR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities. #J-18808-Ljbffr