Specialist, QC Microbiology - Beam Therapeutics

Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The incumbent will support the implementation and execution of core microbiology programs at Beam's manufacturing facility in RTP, North Carolina. The NC manufacturing facility is a greenfield build and will be implemented in 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 programs to commercial within the same facility.

The incumbent will work independently with the planning, implementation, and execution of microbiology workstreams in support of the facility startup plan. These workstreams and duties may include independently authoring and maintaining documentation for the microbiology programs, authoring and leading laboratory investigations, performing testing including but not limited to bioburden, endotoxin, and rapid sterility testing, media growth promotion and gram staining, supporting the implementation and execution of the facility environmental monitoring (EM) program and other responsibilities as outlined below. The incumbent will Independently plan schedules and arrange activities in accomplishing objectives and work on complex problems of diverse scope and technical depth. The incumbent will network and collaborate with senior internal and external personnel on significant matters which may require coordination between organizations. The incumbent will interact and collaborate with colleagues in other Quality teams, manufacturing, engineering and validation to support the implementation of site contamination control goals and standards. The work schedule will provide support for site implementation activities and establishment of routine operations.

Responsibilities:

• Independently author and maintain documentation for the microbiology programs (SOPs, WIs, Laboratory Protocols, Protocol and Trend Analysis Reports, Risk Assessments etc.)
• Independently author, conduct, and lead investigations for the microbiology programs (EM excursions, lab deviations, product OOS's, etc.)
• Perform testing to support the microbiology laboratory programs, including but not limited to bioburden, endotoxin, and rapid sterility testing, media growth promotion and gram staining
• Review and approve laboratory data and documentation for the microbiology programs
• Independently perform trend analysis of methods/ environmental data/ assay controls and standards and draw conclusions
• Independently execute laboratory protocols for the microbiology laboratory programs, author reports and draw conclusions
• Independently author and lead the implementation of laboratory change controls, CAPAs, and continuous improvements
• Lead special projects to support QC laboratory programs and work on complex problems of diverse scope and technical depth
• Independently plan schedules and arrange activities in accomplishing objectives
• Provide training for laboratory and manufacturing personnel
• Support the implementation and execution of the environmental monitoring (EM) program
• Support the incoming testing and management of raw materials
• Support the implementation of the disinfectant efficacy qualification program
• Support the onboarding and implementation of QC lab equipment by authoring CQV lifecycle documents and providing technical assistance during the development and execution of IQ/OQ/PQ protocols. This may require partnering and collaboration with a CQV representative.
• Participate in and support internal and external site audits for the Beam, NC facility.
• Provide assistance for the implementation of the site LIMS; support protocol execution when applicable
• Additional duties as assigned
• 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.

Embodies Beam's cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Bachelor's or Master's degree in a scientific discipline
• 10+ years' relevant experience in the pharmaceutical/biotech industry
• Demonstrated GMP compliant and thorough laboratory study documentation experience (e.g. Test method validation/verification and lab study protocols).
• Experience leading, conducting, and documenting laboratory and/or manufacturing investigations with thorough root cause analysis.
• Experience in GxP requirements of biopharmaceutical manufacturing and testing.
• Experience with compendial safety testing for QC microbiology assays (e.g. bioburden, endotoxin, and rapid sterility).
• Excellent verbal and written communication skills
• Strong technical writing skills
• Strong understanding and application of industry principles, concepts, practices, and standards.
• Strong knowledge of industry practices and guidance
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work equally well individually as within a multi-disciplinary team
• Excellent time management skills
• Consistent delivery of high-quality work at all times