Senior QC Scientist - Program Management

Senior QC Scientist - Program Management   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 Senior QC Scientist - Program Management to join our team. This role serves as the key liaison between Quality Control and clients, ensuring testing requirements are met across internal and external laboratories. The position involves close collaboration with Project Management and other internal teams to establish and maintain testing processes. The successful candidate will play a vital role in coordinating activities, maintaining timelines, and ensuring quality standards are upheld.   Shift: Monday – Friday, 8am – 5pm. Location: Harmans, MD - BWI 100% Onsite   The Role Serve as the primary Quality Control (QC) liaison for clients, internal project teams, and outsourced testing laboratories, ensuring alignment on testing requirements, deliverables, and timelines. Coordinate QC activities across Project Management, Process Development, Analytical Development, Quality Control, and Quality Assurance to support GMP manufacturing readiness. Manage internal and external testing execution, including method transfers, outsourced testing support, and deliverable tracking. Partner with QC sample management and critical reagent teams to oversee sample, reagent, and material inventories, shipments, and logistics. Establish and coordinate stability programs with clients and internal stability teams. Generate, review, and maintain client sampling plans, ensuring accurate sample collection and testing schedules. Develop and maintain project trackers, monitoring QC milestones, deliverables, and testing progress for assigned clients. Align manufacturing schedules with QC testing activities to ensure timely testing and reporting. Communicate QC-related updates, testing results, and project status effectively to clients and internal stakeholders. Support a flexible, compliance-focused environment through participation in training, adherence to campaign-specific requirements, and availability for occasional off-hour or weekend activities. Perform other duties as assigned by management.     The Candidate Minimum Requirements Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, Information Technology, or a related discipline, and 4–8 years of experience working in a Quality Control environment (reduced experience may be considered with higher education in the same field). Strong working knowledge of GMP regulations, ICH guidelines, FDA requirements, USP/EP standards, and other applicable U.S. and EU regulatory expectations. Proven ability to manage multiple priorities in a fast-paced environment, demonstrating strong organizational skills, responsiveness, sound judgment, and attention to detail. Excellent written and verbal communication skills with the ability to effectively collaborate across cross-functional teams, leadership, and external clients. Strong analytical and problem-solving capabilities with the ability to assess complex Quality Control issues and drive effective resolutions. Proficiency with Microsoft Office Suite