Vice President, Head of Manufacturing Operations
Il y a 2 mois
Vice President, Head of Manufacturing Operations - all genders
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 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 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 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
- Exceptional interpersonal, team, and communication skills required
- Strong computer skills including Microsoft Office (Word, Excel, PowerPoint, 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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Vice President, Head of Manufacturing Operations
Il y a 2 mois
Toulouse, France Evotec Temps pleinVice President, Head of Manufacturing Operations - all genders 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...
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