Senior Director Manufacturing
Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.
Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
Position Summary & Role
The Senior Director & Head of Manufacturing will be responsible for the planning, implementation and management of manufacturing facilities, methods, processes, and operations of cGMP and/or BSL-2/3 products and technologies, including upstream and downstream methods related to large scale cell culture isolation to support purification and therapeutic, protein, vaccine, virus, and other Medical Counter Measure (MCM) products including cell and virus banking. This leader has a major responsibility in the complete, proper technology transfer of early and advanced development projects to manufacturing.
Reporting to the Site Head & GM, the Head of Manufacturing will:
- Lead, plan and manage supervision of all cGMP upstream and cGMP downstream manufacturing processes and staff
- Plan and direct the activities of the staff, and assure facility and equipment operations are within cGMP and/or BSL-2/3 compliance
- Ensure complete, proper transfer of technologies and processes to manufacturing through resources managed directly and effective collaboration with supporting departments
- Ensure proper interface with the Quality group for cGMP compliance and documentation
- Provide effective guidance to Procurement, Supply Chain, Logistics, Materials/Warehouse, and their related functions
- Ensure manufacturing systems and processes support the cGMP manufacturing needs of manufacturing facilities and forecasted demand
- Perform complex, in-depth analysis of situations and data and present findings in variety of company settings and adjusted to different audiences, i.e., Customer, Site-Team, Network-Team, etc.
- Develop annual budgets for headcount and technology to support manufacturing
- Ensure unparalleled customer service and satisfaction always working to resolve any issues in a quality and timely manner
- Lead the operations planning and annual goal setting process, talent, and succession planning, OPEX and CAPEX process in collaboration with Finance and HR business partners
- Lead organizational changes to continuously deliver improved business results in the areas of quality, on-time and in-full delivery of product, reliability, and overall competitiveness.
- Extensive experience building and leading large manufacturing or engineering teams with a proven track record of delivering clinical batches.
- Proven experience with planning, leading and overseeing complex upstream and downstream cGMP manufacturing processes.
- In-depth knowledge of cGMP’s, regulatory and quality requirements for biologics and vaccines.
- Demonstrated experience in strategic management, planning, and execution
- Successful history of proven success in , mentoring, coaching and people development
- Excellent verbal and written communication skills
- Strong business, quality, and financial acumen
- Permanent Resident or Citizen of the United States
- Extensive experience and knowledge in managing a biologics facility and staff that includes manufacturing operations, pilot manufacturing, procurement, material/warehouse, logistics, and manufacturing facility management
- Commercial Manufacturing experience
- Ability to manage cross-functional technology teams
- Bachelor’s degree in engineering/life sciences related field.
- 10+ years of direct experience in a Pharmaceutical or Biomanufacturing environment
- 5+ years of direct Pharmaceutical or Biomanufacturing senior leadership at the site level