Director/Senior Director, Manufacturing Job at Beam Therapeutics (Durham)

Job Description

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.

Job Responsibility

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

Requirements

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

Nice to have

MS a plus
experience leading cell/gene therapy manufacturing operations preferred

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Director/Senior Director, Manufacturing

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