Senior QC Scientist - Program Management

Catalent•Harmans, MD

21d•Onsite

About The Position

The Senior QC Scientist - Program Management serves as the key liaison between Quality Control and clients, ensuring testing requirements are met across internal and external laboratories. The role collaborates closely with Project Management and other internal teams to establish and maintain testing processes, coordinate activities, maintain timelines, and uphold quality standards. The position is based 100% onsite at Catalent’s Harmans, Maryland facility and follows a Monday–Friday, 8 a.m.–5 p.m. schedule, with occasional off-hour or weekend activities as needed. The role supports GMP manufacturing readiness by coordinating QC activities across Project Management, Process Development, Analytical Development, Quality Control, and Quality Assurance. It manages internal and external testing execution, including method transfers, outsourced testing, stability programs, sampling plans, sample and reagent logistics, project tracking, and communication of QC status and results. The successful candidate applies scientific, quality, and regulatory principles while supporting a flexible, compliance-focused environment. Catalent’s Harmans/BWI campus includes an FDA-licensed CGMP gene therapy manufacturing facility and a second facility under development. The facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.

Requirements

Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, Information Technology, or a related discipline.
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.
Ability to manage multiple priorities in a fast-paced environment, demonstrating organizational skills, responsiveness, sound judgment, and attention to detail.
Excellent written and verbal communication skills and ability to collaborate with cross-functional teams, leadership, and external clients.
Strong analytical and problem-solving capabilities, including assessing complex QC issues and driving effective resolutions.
Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint), Microsoft Project, and Smartsheet.
Ability to apply scientific, quality, and regulatory principles to operational, compliance, and QC activities.
Highly detail-oriented, with commitment to accuracy, follow-through, and continuous improvement.

Nice To Haves

Project Management experience.
Contract Manufacturing experience.

Responsibilities

Serve as the primary QC liaison for clients, internal project teams, and outsourced testing laboratories, aligning 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 to monitor 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 to clients and internal stakeholders.
Participate in training and follow campaign-specific requirements while supporting a flexible, compliance-focused environment.
Be available for occasional off-hour or weekend activities.
Perform other duties as assigned by management.