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 highly energetic Manufacturing Associates to support start-up and scaling of cGMP manufacturing at our new RTP site. Reporting to the Manager of Manufacturing, the successful candidates will provide manufacturing, operational & technical experience around commissioning, training, qualification, and start-up. 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.
• 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 establishment of long range and business continuity plans.
• Support up to but not limited to multiple areas of GMP production as needed.
• 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 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.
Required Experience & Qualifications:
• BS, MS a plus, in Life Sciences or Engineering with minimum of 0-5 years of relevant experience.
• 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 business acumen.
• 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 supporting and assisting event investigations, Root Cause Analysis (RCA), and CAPA.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.