Vice President, Head of Manufacturing Operations

Evotec

Toulouse, France

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 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 orgazination, 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 implementationwith a focus on manufacture of first-in-class therapeutics
Establish and maintain platform approaches for standardized work; partner with Quality to establish GMP and OE training programs
Establish and model a culture of compliance
Review and approve GMP controlled documentation, ensuring that it meets technical and regulatory requirements
Ensure successful execution of advanced biologics manufacturing technologies
Troubleshoot and/or provide technical expertise to perform, lead, and close investigations
Implement and/or maintain cGMP compliant systems
Provide support for regulatory and site inspections
Develop a culture of compliance, continuous improvement and safety.
Incorporate and expand sustainability into manufacturing operations
Build and develop staff for future roles and career progression; and ensure a culture of safety

Additional 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 (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
Experienced 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 systems
Experienced in the use of electronic systems such as QMS, LIMS, MES/EBR, CMMS, and ERP systems
Active participation/lead technical projects with collaborators and vendors
Previous experience managing the activities of individuals, work groups, and project teams
Strong focus on quality and attention to detail
Possess effective task/time management and strong organizational skills
Motivated, self-starter with strong mechanical aptitude
Expecptional interpersonal, team, and communication skills required
Strong 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 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; commercial campaign support is a plus
Experience in the development, scale-up, and transfer of biologics production processes
Knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancement

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