Senior QC Scientist - Program Management
Catalent Pharma Solutions
Summary
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.
Job description
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.
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
- 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 (Excel, Word, PowerPoint), Microsoft Project, and Smartsheet
- Demonstrated ability to apply scientific, quality, and regulatory principles to support operational, compliance, and Quality Control activities
- Highly detail-oriented with a commitment to accuracy, follow-through, and continuous improvement
Benefits
- Medical, Dental & Vision
- Paid time off
- Paid holidays
- Tuition reimbursement
- Performance bonus
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.