Senior Vice President, Global Manufacturing Operations
About The Position
Senior Vice President, Global Manufacturing Operations This key role is responsible for shaping and overseeing the strategic direction of continuous manufacturing platforms, MSAT, Materials Management, and other relevant support functions within our global manufacturing network. Responsibilities: Leadership and Strategy · Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives · Develop/Build a scalable manufacturing organization to meet the corporate goals · Provide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challenges · Foster a culture of quality and compliance throughout the organization Key Responsibilities: · Manage site performance, ensuring operational excellence; · Review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements; · Plan staff and equipment operations scheduling; · Successfully execute advanced biologics manufacturing technologies; · Troubleshoot and/or provide technical expertise to perform or lead investigations; · Assist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systems; · Provide support for regulatory and site inspections, · Manage OPEX and CAPEX budgets; develop a culture of continuous improvement; · Incorporate and expand sustainability into manufacturing operations; · Build and develop staff for future roles and career progression; · 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
- Validation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
- Strong understanding of process automation (e.g. DeltaV) and BAS systems
- Experienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP systems
- Previous experience managing the activities of individuals, work groups, and project teams.
- Possess strong focus on quality and attention to detail
- Possess effective task/time management organizational skills
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills are a must
- Excellent oral and written communication skills
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
- PhD or Master’s degree in biological or engineering science with 15+ years relevant experience or Bachelor’s degree in biological or engineering science with 20+ years relevant experience
Nice To Haves
- Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines
- In-depth knowledge of equipment, operations, and engineering principles
- Experienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
- Experienced in Development, scale-up, and transfer of biologics production processes
- Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
- Active participation/lead technical projects with collaborators and vendors
Responsibilities
- Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives
- Develop/Build a scalable manufacturing organization to meet the corporate goals
- Provide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challenges
- Foster a culture of quality and compliance throughout the organization
- Manage site performance, ensuring operational excellence
- Review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements
- Plan staff and equipment operations scheduling
- Successfully execute advanced biologics manufacturing technologies
- Troubleshoot and/or provide technical expertise to perform or lead investigations
- Assist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systems
- Provide support for regulatory and site inspections
- Manage OPEX and CAPEX budgets; develop a culture of continuous improvement
- Incorporate and expand sustainability into manufacturing operations
- Build and develop staff for future roles and career progression
- Ensure a culture of safety
Benefits
- comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Executive
