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Camford Capital
Camford Capital

Senior Manufacturing Associate I

Beam Therapeutics

Beam Therapeutics

North Carolina, USA
Posted on Friday, July 21, 2023

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.
  • 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.