Vice President of Manufacturing

il y a 3 semaines


Toulouse, France Hartmann Young Temps plein

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



  • Toulouse, Occitanie, France Evotec WD Temps plein

    Senior Vice President of Biologics Manufacturing - all genders 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...


  • Toulouse, Occitanie, France Evote Temps plein

    Senior Vice President of Biologics Manufacturing - all genders The primary objective of this role is to oversee and direct the advanced clinical and commercial biologics production operations (Cell Culture, Purification, and Support Services) at Evotec's cutting-edge facility. This position will collaborate with MSAT, Quality Assurance, Facilities and...


  • Toulouse, Occitanie, France Evotec WD Temps plein

    Vice President of Operations, Biologics Manufacturing Role Overview: The Vice President of Operations will be responsible for overseeing the advanced clinical and commercial biologics production processes at Evotec WD's cutting-edge facility. This leadership position will collaborate closely with various departments including Global MSAT, Quality...


  • Toulouse, Occitanie, France Evote Temps plein

    Senior Vice President of Operations, Biologics Manufacturing The main objective of this position is to oversee and direct the advanced clinical and commercial biologics production processes (Cell Culture, Purification, and Support Services) at Evote's cutting-edge facility. This role will collaborate with Global MSAT, Quality Assurance, Facilities &...


  • Toulouse, Haute-Garonne, France Hartmann Young Temps plein

    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...


  • Toulouse, France Hartmann Young Temps plein

    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...


  • Toulouse, France Hartmann Young Temps plein

    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...


  • Toulouse, France Hartmann Young Temps plein

    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...


  • Toulouse, Occitanie, France Evote Temps plein

    Position Overview: The main responsibility of this role is to oversee and direct the advanced stages of clinical and commercial biologics manufacturing operations, including Cell Culture, Purification, and Support Services. Key Responsibilities: Collaborate with various departments such as MSAT, Quality Assurance, Facilities and Engineering, PMO, OE, and...


  • Toulouse, Occitanie, France Hartmann Young Temps plein

    Position Overview:The primary responsibility of this role is to oversee and direct the advanced-stage clinical and commercial biologics production processes (including Cell Culture, Purification, and Support Services) at Hartmann Young's cutting-edge facility. This position will collaborate with various departments such as MSAT, Quality Assurance, Facilities...


  • Toulouse, Occitanie, France Evotec WD Temps plein

    Job SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Biologics Manufacturing Operations team at Evotec WD. As the Head of Biologics Manufacturing Operations, you will be responsible for overseeing the late stage clinical and commercial biologics manufacturing operations at our state-of-the-art facility.Key...


  • Toulouse, Occitanie, France Evote Temps plein

    Job SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Biologics Manufacturing Operations team at Evotec. As the Head of Biologics Manufacturing Operations, you will be responsible for overseeing the late stage clinical and commercial biologics manufacturing operations at our state-of-the-art facility.Key ResponsibilitiesLead...


  • Toulouse, Occitanie, France Evotec Temps plein

    Job Summary:The Senior Director, Head of Biologics Manufacturing Operations will lead and guide the late stage clinical and commercial biologics manufacturing operations at Evotec's state-of-the-art facility. This position will partner with cross-functional teams to ensure plant readiness and ongoing operational success.Key Responsibilities:Manage plant...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Job Summary:Just Evotec Biologics EU is seeking a highly skilled Manufacturing Associate III to join our team. As a key member of our manufacturing operations team, you will be responsible for ensuring the successful execution of clinical and commercial manufacturing operations while maintaining cGMP compliance.Key Responsibilities:Initiate quality records,...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Job SummaryWe are seeking a highly skilled Manufacturing Associate III to join our team at Just Evotec Biologics EU. This role will be responsible for the successful execution of clinical and commercial manufacturing operations while ensuring compliance with cGMP regulations.Key ResponsibilitiesInitiate quality records, including non-conformances,...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Manufacturing Associates III play a crucial role in executing process protocols, overseeing machinery and workflows, and performing essential tasks such as sampling and routine upkeep of laboratory instruments to support downstream production activities. The individual is expected to adhere to and follow established protocols for safety standards, cGMP...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Manufacturing Associate III Job Overview At Just Evotec Biologics EU, we are seeking a dedicated **Manufacturing Associate III** to play a crucial role in our clinical and commercial production processes. This position is essential for ensuring adherence to **current Good Manufacturing Practices (cGMP)** while executing various manufacturing tasks. The...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Manufacturing Associate III Job Overview This role at Just Evotec Biologics EU encompasses the proficient execution of both clinical and commercial production activities while adhering to current Good Manufacturing Practices (cGMP). Manufacturing Associates III are tasked with carrying out production processes, overseeing equipment functionality, and...

  • Manufacturing Associate III

    il y a 2 heures


    Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    **Job Summary**Just Evotec Biologics EU is seeking a highly skilled Manufacturing Associate III to join our team in the production of biotherapeutics. As a key member of our manufacturing team, you will be responsible for executing process recipes, monitoring equipment and processes, and performing basic tasks such as sampling and routine maintenance of lab...

  • Digital Transformation Leader

    il y a 2 semaines


    Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    About Just – Evotec Biologics Just – Evotec Biologics, wholly-owned by Evotec SE, is a leading platform company that integrates the design, engineering, development, and manufacture of biologics. With deep expertise in protein, process, and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access...