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Job: Manager, Quality Control Operations, Beam Therapeutics, RTP, NC
Manager, Quality Control Operations
RTP, NC 27709 United States
The Quality Control Operations Manager will be responsible for implementation and oversight of core Quality Control programs at Beam’s manufacturing facility in RTP, North Carolina. The NC manufacturing facility is a greenfield build and will build out in various phases over a 6-8 Year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility will start as a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility.
The incumbent will drive critical QC workstreams in support of the facility startup plan. These workstreams include implementation of the QC Sample Management program, implementation of the QC Incoming Materials program, and support of the LIMS implementation project. The position will report into the Head of Quality Control.
Establish and maintain the QC Sample Control program, which includes management of QC samples, reference samples, retain samples, and stability samples
Responsible for implementation of systems to ensure compliant receipt, storage, tracking, transfer, and retrieval of samples
Serve as LIMS QC Administrator; partner with IT Administrator to ensure LIMS validation and implementation activities are delivered as per the timeline
Establish and maintain LIMS SOPs and work instructions; develop content for LIMS training programs
Establish QC Incoming Materials Program and Laboratory Testing
Partner with CQV representative to ensure equipment qualification and release milestones are met
Participate in GMP validation activities including the development and execution of IQ/OQ/PQ testing.
Assist with or drive laboratory equipment selection and procurement
Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.
Bachelors in a scientific discipline.
6+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
Knowledge of QC business processes inclusive of sample workflow and testing, certificate of analysis generation, reporting and process trending.
Experience with LIMS or equivalent qualified software system
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Excellent team building, leadership and management skills.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high-quality work at all times.
Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
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