RESPONSIBILITIES

• Develop and implement a strategic plan to bring a new facility on-line, including an effective ramp-up plan and ensure the new site is PAI ready by the end of calendar year 2024 through collaboration with already established Quality, CMC and development teams.
• Develop and lead effective hiring and staff onboarding strategies to meet the established readiness goals.
• Manage work products of a teams while taking personal responsibilities for completing deliverables as needed.
• End to end responsibility for the commercial site including site P&L, quality, compliance, execution, operational performance, and administration of the site.
• Ensure site compliance standards with internal procedures and all applicable regulations.
• Demonstrates a high level of vision, leadership, and business acumen.
• Direct the development, growth and after launch ongoing profitability of the site by ensuring the site is properly staffed to meet demand.
• Drive a culture of continuous improvement in the facility using operational excellent tools and processes.
• Implement visual management systems and effective shift exchange processes.
• Develop and implement a review and reporting process for the site to evaluate progress against quality and business objectives and to discuss and decide future site priorities.

QUALIFICATIONS

• The candidate is expected to be onsite in Sacramento, California regularly.
• Bachelor’s degree in biology, chemistry, or other relevant disciplines.
• Experience in CMC and Technical Operations preferred
• Excellent understanding of current Good Manufacturing Practices (cGMP) and regulatory requirements for ATMPs/ cell therapy products
• A minimum of ten (10) years’ related experience in the pharmaceutical/biotech industry with demonstrated increasing responsibility an equivalent combination of education and experience.
• Direct cell therapy experience preferred.
• Demonstrated track record of driving business results and improving operations.
• Demonstrated track record of running compliant organizations with good inspection histories or demonstration of improving inspection histories.
• Previous experience leading or supporting regulatory inspections in a management capacity.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Effective leadership and team building capabilities, with the ability to motivate and develop high performing teams.
• Working knowledge of regulatory guidelines and expertise in operating in a phase appropriate environment.
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
• Understanding of basic scientific/technical concepts.
• Strong oral, written, listening skills Proficiency with MS Office.