Head of Manufacturing Technology & Supply
Reporting to: Chief Technical Officer
Reporting to the CTO, the Head of Manufacturing Technology and Supply will provide strategic leadership and oversight of all internal and external manufacturing operations as well as global supply chain activities, including the planning and execution of global expansion into new markets, to achieve on-time delivery of high-quality products to patients in the most efficient and cost-effective way.
The incumbent will lead the team to successful completion of strategic and pipeline projects through effective project management and identification and escalation of risks. Assigned projects may include technical transfer (analytical/process), execution of regulatory strategies and commitments, process validation, operational efficiency, capacity planning, and distribution. In addition, this person will own and drive program risk management and be accountable for budgetary planning and control.
Success in the role will require effective collaboration with all internal functions, particularly Technical Development, Quality and CMC Regulatory and externally with our CDMOs and partners.
- Provide strong leadership, set the vision, and architect the path to delivering rapid, flawless, compliant and cost-effective delivery of consistently high-quality products
- Create world-class, state-of-the-art, cell and gene therapy MSAT and supply chain processes, and associated IT infrastructure. Actively engage in external benchmarking to maintain competitive advantage.
- Build and develop a highly performing manufacturing and supply chain team that is focused on excellence and continuous improvement
- Implement and execute upon the manufacturing technology roadmap
- As the head of the function, provide leadership and direction, lead critical milestone reviews, decision making, issue resolution, risk mitigation and continuous improvement of processes to ensure commitments are met
- Effectively communicate with team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects, mentor and coach the team
- Build strong collaborative relationships with internal and external stakeholders to ensure effective and reliable demand forecasting and supply planning that ensures adequate manufacturing capacity and adequate product and raw material inventory availability at the right time
- Work closely to support GMP and non-GMP production activities and product distribution activities and support functional areas during long range planning / budget planning
- Assist in the creation and deployment of standards around project and workload management to improve efficiency, expand functional capabilities and streamline use of resources
- Ensure that department objectives are in line with company objectives and be fully accountable to achieve goals, strategic directives and ensure that targeted project milestones are met within agreed upon timelines
- Serve as a role model to foster a culture of high performance and trust
Knowledge & Experience
- Substantial experience in the pharmaceutical industry leading manufacturing science and technology (MSAT/ASAT) within a CGT environment ensuring strong and robust manufacturing and analytical processes are delivered
- Proven expertise in leading and developing global supply chain activities within CGT
- Proven experience and knowledge in the development and scale up of HSC and LVV manufacturing processes
- Experienced in building strategic partnerships with external manufacturers/CMOs and service providers to ensure successful and effective execution on strategic plans
- Working knowledge of biotechnology, GMPs, and drug development pathway through to commercialization
- Experienced in leading the implementation of processes, SOPs, and IT systems to support manufacturing and supply chain processes
- Proven track record of independently managing and successfully driving complex projects within the biotech industry. Able to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple projects simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
- Prior experience and involvement in regulatory submissions and risk management
Skills & Abilities
- · Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective. · Able to manage budgets, resources, and associated project plans for area of responsibility with internal and external stakeholders Leadership, Collaboration, and Influence · A strong and inspiring people leader with a coaching style and the ability to build high performing teams · A thoughtful and pragmatic communicator and influencer with proven ability to build effective relationships internally and externally to the organization that enable strong collaboration between all key stakeholders to achieve critical milestones
- BSc in a relevant scientific discipline such as Biotechnology, Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or another relevant field