The Head of Process Science will establish and lead our Manufacturing Science, Program Management & Tech Transfer interfaces to drug development partners at our Holly Springs site. This is a one-of-a-kind opportunity to develop and define the future business model of what will be the largest cell culture manufacturing site in North America. This senior leader will be essential in driving our new customer base as well as ensuring complete end-to-end Process Development and Manufacturing Science as Drug Product capabilities are being built to form an entire Process Science team. They will function as the key overall customer interface for new products, processes and changes from partners and programs. All strategic, tactical and operational aspects of the group will support the bulk drug substances and ensure close collaboration with Manufacturing, Global Engineering & Facilities, Quality, Regulatory, CMC, Business Development and Tech Development in meeting the business objectives. The Head of Process Science will collaborate closely with our Denmark location to ensure alignment across key areas and will have full accountability for adherence to cGMP requirements and regulations. This role will be highly visible in our community and our industry, and presents a unique chance to build something extraordinary.
• Ability to act independently and influence decisions
• Excellent communication skills and ability to interact/collaborate cross-functionally
• Strong organizational and time management skills
• Customer service focused and strong conflict resolution skills
• Strong presentation and public speaking skills
• Oversee all site related processes for Manufacturing Operations
• Develop and execute performance and organizational management for staff including Scientists, Engineers, Managers & Directors
• Direct tactical and operational activities for process staff. Ensures personnel are adequately trained on processing activities and safety requirement to execute their roles per established procedures.
• Manage customer relationship from the site and develop and build organization for handling interface including establishing the program team, tech transfer team and process development organization
• Develop capacity and resource assessments, including equipment capacities and resource planning and allocation to ensure adequate staffing to meet production schedules.
• Provide leadership in environmental and safety compliance
• Ensure implementation of safety programs in Process Science
• Support regulatory submissions and inspections
• Develop and maintain budget (expense and capital) for Drug Substance, Manufacturing Science and Program Management teams
• Perform budgetary tracking and decision making for department expenses and capital expenditures for the site
• Ensure review of batch records and resolution of manufacturing related issues for release of batches
• Ensure overall compliance with personnel and workplace safety standards
• Bachelor's Degree in Science/Engineering field is required. Master's Degree or PhD is preferred.
• Minimum of 12 years' experience in Process Science for a pharmaceutical company or CDMO is required
• Experience working with biologics drug manufacturing is required
• Demonstrated track record of success and progressively increasing responsibilities throughout career is required
• Prior leadership experience is required
• Experience working for a large pharmaceutical or biotech company
• CDMO or other client-focused experience
• Global collaboration experience