Vice President of Manufacturing
il y a 1 mois
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 our client's state-of-the-art 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 include recruiting and building 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, 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, focusing on the 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 the 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; 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.
To find out more about this opportunity reach out to me at Vincent.mackay@hartmannyoung.com
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