Position Overview:

Beam is expanding our geographical footprint to RTP, NC with the recent announcement of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA. We are looking for a highly energetic Director of Manufacturing Sciences & Technology to support start-up and scaling of cGMP manufacturing at our new RTP site. Reporting to the Plant Manager Site Head, cGMP Manufacturing, and in partnership with Process Development, the successful candidate will be the single point of accountability for all aspects of the manufacturing process at the site, while providing operational & technical leadership throughout start-up. The Director of Manufacturing Sciences & Technology will develop systems and lead internal tech transfers, provide technical support and subject matter expertise for process equipment to execute cGMP clinical manufacturing, and prepare the site for process validation for commercial manufacturing. This leader will hire and develop staff to support site operational readiness and provide technical support to manufacturing. As a key member of the North Carolina Site Leadership Team, the individual will develop operational strategies to build a nimble, flexible, efficient operation and ensure safe and reliable supply of products. This individual will establish comprehensive plans, procedures, systems, and budgets that are consistent with company objectives. 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 successfully interface with multidisciplinary teams and build strong cross-functional relationships, including Process Development partners located in Cambridge, MA.

Responsibilities:

• Cultivate Beam's culture and our values-driven organization focused on people.
• Define and implement the mission, vision, and strategy for the Beam NC Site Manufacturing Sciences & Technology team.
• Ensure safety, compliance, efficiency, and sustainability throughout tech transfer and 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, with a focus on driving process improvements in manufacturing.
• Prepare and maintain departmental budget and workforce model.
• Develop and implement systems for process oversight to monitor operational health, inform strategic decisions, and present materials at management reviews.
• Build a collaborative and empowered team that put patients first.
• Recruit, retain, and develop a motivated and diverse team.
• Represent department during audits and regulatory inspections.
• Establish and maintain strong relationships at the site and cross-functionally.
• Develops and maintains detailed tech transfer 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.
• Owns and contributes to development and implementation of tech transfer and manufacturing documents (batch records, procedures, and technical reports).
• Lead and/or assist with manufacturing deviation investigations and change controls.
• Manages tech transfer and process scale-up in partnership with PD and Manufacturing.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.
• This is an on-site role. Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
• Must be able to work onsite.

Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 10 years of relevant work experience, or a Master's degree with a minimum of 15 years of relevant work experience, or a Bachelor of Science degree in Engineering or Life Sciences with a minimum 20 years of relevant work experience.
• Proven experience as a direct manager of people and as a leader in a Manufacturing Sciences & Technology; 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.