Scientist, Data Review

Scientist, Data ReviewAbout SiteCatalent’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 SummaryWe 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 5:00pmLocation: Morrisville, NC100% OnsiteThe RolePerform independent Level 2 review of analytical data for raw materials, packaging components, in-process, finished product, and stability samplesReview 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 methodsConduct audit trail reviews to ensure all data changes are traceable, justified, and compliant with data integrity (ALCOA+) requirementsReview raw data, calculations, and documentation for accuracy, completeness, and data integrity complianceVerify system suitability, instrument performance, and method compliance during data reviewSupport investigations including Out of Specification (OOS), Out of Trend (OOT), and deviations, and implement corrective and preventive actions (CAPA)All other duties as assignedThe CandidateMinimum RequirementsBachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field of studyMinimum 5+ years of experience in a pharmaceutical Quality Control (QC) laboratory environmentStrong 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 expectationsProficiency in reviewing data from HPLC, GC, FTIR, Ultraviolet (UV), and wet chemistry techniquesMust be able to wear safety glasses and a respirator when requiredMust have 20/20 vision (with or without corrective lenses)Preferred Skills & BackgroundFamiliarity with laboratory systems such as Empower, Laboratory Information Management System (LIMS), and TrackWiseWhy You Should Join CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition ReimbursementCatalent 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.Visit Catalent Careers to explore career opportunities.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 View email address on click.appcast.io. 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.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Morrisville, NCType: Full time