Manufacturing Associate / Sr. Manufacturing Associate

Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building 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 potential 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 Therapeutics is looking for a highly energetic Manufacturing Associate/Sr. Manufacturing Associate to support GMP operations in 2025 at our site in Research Triangle Park, NC.   Reporting to Sr Leadership in Manufacturing, the successful candidates will provide manufacturing, operational & technical experience around commissioning, training, qualification, and routine GMP Operations. The ideal candidates will have experience in cell or gene therapy, along with demonstrated ability in a GMP environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships in a team environment.

Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on people.
• Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing.
• 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.
• Support up to but not limited to multiple areas of GMP production as needed.
• Support 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 /equipment qualification and training for the ability of meeting process and regulatory expectations.
• Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
• Assist MFG support functions in relation to manufacturing deviation investigations and change controls / CAPAs.

Qualifications:

• BS, MS a plus, in Life Sciences or Engineering with minimum of 0-10 years of relevant experience. Level will be determined based on a combination of experience and education.
• Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
• Proven experience as a contributor in a cGMP manufacturing operation; experience leading cell/gene therapy manufacturing operations strongly preferred.
• Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
• Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
• Demonstrated entry level business acumen.
• Dynamic interpersonal skills and the ability to manage through influence, while being part of a team.
• 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.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.