Scientist, Data Review

Scientist, Data Review

About Site

Catalent’s Morrisville facility, located in the heart of North Carolina’s Research Triangle Park, is a modern site dedicated to supporting advanced pharmaceutical development and manufacturing. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. Its strategic location within a leading life sciences hub fosters strong connections with industry partners and access to top talent, making it an exciting place to contribute to meaningful work that impacts global health.

Position Summary

We have an opportunity for a Scientist, Data Review to join our team. This role is responsible for reviewing and verifying analytical data for raw materials, packaging components, in-process, finished product, and stability testing. You will ensure accuracy, completeness, and compliance with USP, EP, JP, and internal cGMP requirements. The position plays a key role in maintaining data integrity and meeting regulatory expectations.

Shift: Monday - Friday, 8:00am to 5:00pm
Location: Morrisville, NC
100% Onsite

The Role

• Perform independent Level 2 review of analytical data for raw materials, packaging components, in-process, finished product, and stability samples
• Review and verify analytical test results generated using techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FTIR), Ultraviolet (UV), and wet chemistry in accordance with USP, EP, JP, and in-house methods
• Conduct audit trail reviews to ensure all data changes are traceable, justified, and compliant with data integrity (ALCOA+) requirements
• Review raw data, calculations, and documentation for accuracy, completeness, and data integrity compliance
• Verify system suitability, instrument performance, and method compliance during data review
• Support investigations including Out of Specification (OOS), Out of Trend (OOT), and deviations, and implement corrective and preventive actions (CAPA)
• All other duties as assigned

The Candidate

Minimum Requirements

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field of study
• Minimum 5+ years of experience in a pharmaceutical Quality Control (QC) laboratory environment
• Strong experience in data review, raw material testing, and compendial methods (USP/EP/JP)
• Knowledge of chromatographic and analytical techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Fourier Transform Infrared Spectroscopy (FTIR)
• Strong understanding of current Good Manufacturing Practices (cGMP), data integrity, and regulatory expectations
• Proficiency in reviewing data from HPLC, GC, FTIR, Ultraviolet (UV), and wet chemistry techniques
• Must be able to wear safety glasses and a respirator when required
• Must have 20/20 vision (with or without corrective lenses)

Preferred Skills & Background

• Familiarity with laboratory systems such as Empower, Laboratory Information Management System (LIMS), and TrackWise

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective day one of employment
• Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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