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 highly energetic Manufacturing Associates to support start-up and scaling of cGMP manufacturing at our new RTP site. 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.
Key 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 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. Final level and responsibilities will vary depending on candidate experience.
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
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.
