Scientist, Data Review

Dormont Manufacturing Co; Nouvelle-Calédonie; Sur place; EUR 61 376 - 96 449; Plein temps

Avantages offerts par ce poste

Defined career path

Diverse culture

Career growth

PTO & holidays

Community initiatives

Benefits day one

Tuition reimbursement

Résumé du poste

Catalent is seeking a Scientist, Data Review to join our Morrisville, NC team. This role focuses on reviewing and verifying analytical data for raw materials, packaging, in-process, finished product, and stability testing to ensure accuracy, completeness, and compliance with USP, EP, JP, and internal cGMP standards.

The candidate will perform Level 2 data reviews, verify instrument performance, support OOS/OOT investigations, and contribute to CAPA activities while maintaining data integrity

Qualifications

• 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 HPLC, GC, FTIR.
• Strong understanding of cGMP, data integrity, and regulatory expectations.
• Proficiency in reviewing data from HPLC, GC, FTIR, UV, and wet chemistry techniques.

Responsabilités

• Perform independent Level 2 review of analytical data for materials and products.
• Review test results generated using HPLC, GC, FTIR, UV and wet chemistry per USP/EP/JP and in-house methods.
• Conduct audit trail reviews to ensure data changes are traceable and compliant (ALCOA+).
• Review raw data, calculations, and documentation for accuracy and integrity.
• Verify system suitability, instrument performance, and method compliance during data review.
• Support investigations including OOS, OOT, deviations, and CAPA implementation.
• All other duties as assigned.

Connaissances

Data review

HPLC

GC

FTIR

cGMP knowledge

Regulatory compliance

Analytical testing

Formation

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Master’s degree in Chemistry/Pharmaceutical Sciences

Outils

Empower

LIMS

TrackWise

Description du poste

Scientist, Data Review

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

Benefits

• 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 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 [e-mail]. 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 for the application or hiring process.