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Manufacturing Supervisor/Sr. Manufacturing Supervisor
Updated on 1/30/2023
Locations
Research Triangle, Durham, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • Bachelor of Science Degree in Biology, Chemistry, Biotechnology, or applicable field with 3-6 years' experience or equivalent level of education and/or related experience will be considered. Level will be determined based on a combination of experience and education
  • M-F Day shift operation but must be willing to support off-hours or weekends as required
  • Ability to routinely lift over 35 lbs
  • Proven experience as a leader and key contributor in a cGMP manufacturing operation; experience leading cell/gene therapy manufacturing operations strongly preferred
  • Demonstrated 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 as it relates to shift operations, with impact to financial stewardship for the organization
  • Dynamic interpersonal skills and the ability to manage through influence across multiple levels of the organization
  • 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
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
  • Understands cGMP and cGDP and ensures all documentation is being filled out correctly, training is current, and all Quality requirements are being followed
  • Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies related to the manufacturing process
  • Partners with Quality to ensure a quality and compliant manufacturing environment
  • Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations
  • 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
  • Represent department during audits and regulatory inspections
  • Establish and maintain strong relationships at the site and cross-functionally
  • Assures alignment of internal manufacturing schedules and that operations meets these timelines on daily/weekly basis
  • 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
Beam Therapeutics

501-1,000 employees