Company Overview:
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
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.
