Technician II, Central Services

Technician II, Central Services About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Summary We have an opportunity for a Technician II, Central Services to join our team. In this role, you will support manufacturing processes in Central Services by applying broad knowledge of theories and principles to solve operational and routine tasks. You will contribute to the production of bulk biologics from microbial and cell culture systems for Phase I/II and commercial GMP manufacturing. This position reports to the Central Services Supervisor assigned to the shift. Shift work and weekend work may be required at times. Shift: Day shift 7am-7pm on a 2-2-3 rotation Location: Harmans, MD - BWI 100% Onsite The Role Complete and maintain Batch Production Records and GMP documentation in compliance with SOPs, regulatory requirements, and data integrity standards. Author, revise, and manage manufacturing documentation, including SOPs, batch records, protocols, deviations, CAPAs, and summary reports. Support technology transfer activities by partnering with Process Development and MS&T teams to introduce new processes into GMP manufacturing. Initiate, investigate, and close deviations and CAPAs, including leading root cause investigations and implementing corrective actions. Troubleshoot manufacturing processes and equipment issues while coordinating with Facilities, Engineering, and Validation teams to ensure operational readiness. Collaborate with production leadership to develop, optimize, and implement manufacturing processes that meet operational objectives and timelines. Recommend and support procurement of manufacturing equipment, supplies, and resources to enhance production efficiency. Participate in facility expansion, equipment qualification, validation, and continuous improvement initiatives. Perform and oversee cleaning and maintenance activities for manufacturing equipment and controlled production environments. Partner cross-functionally with internal teams and external clients during manufacturing campaigns, providing technical support, project coordination, and operational expertise. Perform other duties as assigned The Candidate Minimum Requirements High School diploma or GED with 2-4 years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred Associate degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in upstream or downstream biologic production processes under GMP compliance preferred Bachelor’s degree in a Scientific, Engineering, or Biotech field with 1-3 years of experience in upstream or downstream biologic production processes under GMP compliance preferred Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports Thorough knowledge of current Good Manufacturing Practices and relevant safety