Senior QC Scientist - Program Management

Catalent•Harmans, MD

19d•$110,000 - $120,000•Onsite

About The Position

Catalent is seeking a Senior QC Scientist - Program Management to serve as the key liaison between Quality Control and clients, ensuring testing requirements are met across internal and external laboratories. The role works 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/BWI campus in Maryland and follows a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The site supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. The successful candidate will coordinate QC testing and project deliverables, support GMP manufacturing readiness, manage client sampling and stability programs, and communicate testing progress and results to clients and internal stakeholders. The role also requires participation in training, compliance with campaign-specific requirements, and availability for occasional off-hour or weekend activities.

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.
Ability to manage multiple priorities in a fast-paced environment, with strong organizational skills, responsiveness, sound judgment, and attention to detail.
Excellent written and verbal communication skills, including the ability to collaborate across 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, and PowerPoint), Microsoft Project, and Smartsheet.
Ability to apply scientific, quality, and regulatory principles to operational, compliance, and QC activities.
High attention to detail and 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, including occasional off-hour or weekend activities.
Perform other duties as assigned by management.