AavantiBio is an emerging biotechnology company co-founded by Barry Byrne, M.D., Ph.D., and Manuela Corti, P.T., Ph.D. AavantiBio's leading gene therapy program is in Friedreich's Ataxia (FA), a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. Headquartered in the Boston area, AavantiBio benefits from strategic partnerships with the University of Florida's renowned Powell Gene Therapy Center and the MDA Care Center at UF Health, where Dr. Byrne and Dr. Corti maintain their research and clinical practices.
Position: Vice President of Manufacturing
Reports to: Chief Technical Officer
Overview of Position
The VP of Manufacturing will be responsible for leading the clinical and commercial Manufacturing operations for AavantiBio’s leading gene therapy program. This position will oversee the technical operations strategy and development for utilizing external partnerships with a future focus on internal capabilities. This position will be responsible for the clinical phase production of AavantiBio’s leading gene therapy program and future internal growth capacity to enable AavantiBio to manufacture clinical and commercial Good Manufacturing Practices (GMP) material internally. Vice President of Manufacturing will be required to demonstrate the ability to oversee building and production for a GMP facility. This leader will advise and influence the AavantiBio Leadership Team on manufacturing best practices (policy, governance, strategic planning, operating model, and processes, etc.).
Responsibilities – Including but not limited to:
- Develop department initiatives and execution plans in alignment with corporate goals.
- Lead and support AavantiBio’s patient-focused culture across the organization and its partners.
- Ensure quality and safety are understood to be the responsibility of all persons involved directly or indirectly within the organization.
- Provide leadership and direction across the manufacturing and engineering departments in compliance with current Good Manufacturing Practices (cGMP’s), Industry Guidelines & Regulations, and corporate procedures.
- Hire, train, and supervise direct reports and encourage continued growth and development of team members.
- Create an open, inclusive, and collaborative environment to support company and department goals and initiatives.
· Provide leadership and direction for all aspects of the Operations function for Regulatory licensure activities including representing their areas of responsibility during agency inspections and formulation of inspection responses.
· Oversee the communication of business performance against key performance indicators and associated metrics for production plan adherence and other Operational KPIs.
· Reduce risk through effective risk mitigation programs that focus on appropriate second source strategies, increasing capacities of our contract manufacturers and shortening supply chain cycle times.
· Oversee technical operations team to assure departments are collaborative and efficiently progressing per company goals and initiatives.
· Aid and collaborate on changing job responsibilities with team members as AavantiBio grows and achieves success.
Internal Manufacturing Responsibilities
· Support in developing technological strategy and implementation of the determined path.
· Manage headcount and participate in setting the organization's annual budget and quarterly forecasting processes.
· Effectively recruit, retain, develop, and lead a team of professionals.
· Establish, communicate, and sustain metrics to monitor manufacturing performance and compliance, and report and present in management meetings as appropriate applying Operational Excellence methodologies. Foster an inclusive, collaborative, patient-focused culture across all teams.
· Identify bottlenecks and roadblocks associated with establishing successful manufacturing/clinical plans, develop options available for resolving issues, develop key conclusions and recommendations based upon the plans, and effectively and proactively communicate options, conclusions, and recommendations to management as needed.
· Represent AavantiBio as core representative for all manufacturing operations for a future facility.
External Manufacturing Responsibilities
· Guide and oversee AavantiBio’s current benchtop science through clinical and commercial production.
· Establish procedures and policies regarding commercial operations with CDMO.
· Minimize variability and align operations, demand planning, and sourcing to ensure minimum financial impact and uninterrupted manufacturing operations and cold chain workflow.
· Develop comprehensive manufacturing strategy for both CDMOs / CMOs for immediate demand and alignment with in-house Manufacturing capabilities.
· Oversee management of CDMO from all aspects of production and process development of AavantiBio’s drug product candidate.
· Act as a first-line resource to manage the interface between CMO functions pertaining to operations and liaise with internal teams to address issues as needed.
· Bachelor's degree in Life Sciences, Engineering, or related business administration (with a certification in logistics or planning preferred).
· 15+ years of relevant operations experience for clinical and commercial production in the pharma/biotechnology industry.
· Comprehensive understanding of ASTM E2500, US/EU/ROW regulatory guidelines, quality principles, environmental health and safety (EH&S) regulations, cGMP requirements for clinical and commercial pharmaceutical manufacturing globally (ICH Q7), and the latest industry guidelines & best practices.
· 5+ years cell and gene therapy experience.
· Experience leading new site construction, establishing a partnership of new operations, and global commercial cGMP manufacturing operations.
· Ability to travel: ~25%
· Relocation required upon site selection for future facility build.
· Experience in supporting global filings and a successful track record in completing pre-approval and post-licensure inspections.
· Experience collaborating and managing multiple workstreams: Engineering, MSAT, Process Development, Manufacturing, CDMO partnerships, automation, quality.
· Self-motivated, reliable, and solution-driven.
· Excellent interpersonal, verbal, and written communication skills to build and maintain effective working relationships.
· Ability to build, motivate, and lead a team to execute and achieve company goals while maintaining schedule, scope, and budget.
· Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AavantiBio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at AavantiBio are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.