Senior Director, Head of Biologics Manufacturing Operations
il y a 3 jours
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 performance, ensuring operational excellence
- Establish the hiring strategy and implement high-performing team tactics to accelerate new technology platform implementation
- 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
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)
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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