Manufacturing Associate l/II

Role Summary

Beam Therapeutics is seeking a highly energetic Manufacturing Associate/Sr. Manufacturing Associate to support GMP operations at the Research Triangle Park, NC site. Reporting to senior leadership in Manufacturing, the role will provide manufacturing, operational and technical experience around commissioning, training, qualification, and routine GMP operations. The ideal candidate will have experience in cell or gene therapy within a GMP environment and the ability to interface with multidisciplinary teams to build strong cross-functional relationships.

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.

Education

• BS or MS in Life Sciences or Engineering (a plus).

Additional Requirements

• 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.