Director/Sr. Director, Manufacturing

Position Overview:

Beam is looking for a highly energetic Director / Senior Director, Manufacturing, to lead our internal manufacturing team.  The Director / Senior Director, Manufacturing will be responsible for teams manufacturing multiple modalities, including mRNA, Lipid Nanoparticles, and Autologous Cell Therapy, for clinical and commercial supply.   As a key member of the North Carolina Site Leadership Team, the individual will develop and implement operational strategies to build a nimble, flexible, efficient operation and ensure safe and reliable supply.  The ideal candidate will be a seasoned leader with a demonstrated track record of building high performing teams.  They will also possess the ability to interface successfully with multidisciplinary teams and build strong cross-functional relationships. 

Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on people.
• Define and implement the mission, vision, and strategy for Beam internal cGMP Manufacturing, supporting both clinical and commercial operations.
• Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations.
• Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
• Champion development of a learning culture that embraces innovation and continuous improvement.
• Prepare and maintain departmental budget and workforce model.
• Support establishment of long range and business continuity plans.
• Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions, and present materials at management reviews.
• Build collaborative and empowered teams that put patients first.
• Recruit, retain, and develop high-performing and diverse teams.
• Represent department during audits and regulatory inspections.
• Establish and maintain strong relationships at the site and cross-functionally.
• Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines.
• Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
• Support facility and equipment design and qualification for ability to meet process and regulatory expectations.
• Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
• Lead and/or assist with manufacturing deviation investigations and change controls.
• Supports tech transfer and process scale-up in partnership with Process Development and Manufacturing Science & Technology.
• Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.

Qualifications:

• BS, MS a plus, in Life Sciences or Engineering with minimum of 15 years of relevant experience.
• Proven experience as a direct manager of people and as a leader in clinical and commercial cGMP manufacturing operations; experience leading cell/gene therapy manufacturing operations preferred.
• Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
• Strong background in drug development and regulatory requirements.
• Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
• Demonstrated business acumen, including long range planning and budget management.
• Dynamic interpersonal skills and the ability to manage through influence.
• Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership and drive.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Travel for in-person interactions with cross-functional stakeholders.
• This is an on-site position.