Manufacturing Supervisor/Sr. Manufacturing Supervisor

Position Overview:

Beam has expanded our geographical footprint to Research Triangle Park, NC with the recent construction of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA.  We are looking for a highly energetic Manufacturing Supervisor/Sr. Manufacturing Supervisor, to support start-up and scaling of cGMP manufacturing at our new RTP site. Reporting to the Sr Manager of Manufacturing, the successful candidate will provide manufacturing, operational & technical experience around commissioning, training, qualification & start-up. The Manufacturing Supervisor will be responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site. The ideal candidate will have experience in cell or gene therapy, along with demonstrated supervisory experience 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. The ideal candidate will have proven experience leading a shift or team of associates.

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.
• 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.

Required Experience & Qualifications:

• Bachelor of Science Degree in Biology, Chemistry, Biotechnology, or applicable field with 4-6 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.