Quality Control Scientist - Chromatography Specialist

ChromaGenix; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

ChromaGenix in Raleigh, NC seeks a Quality Scientist to establish a dedicated QC function, collaborating with R&D and quality teams to deliver analytical support, method development, and validation for peptide ligand technology and finished products.

The role includes supporting chromatography characterization (HPLC/UPLC/GC), routine batch release testing, data integrity, and regulatory compliance (ISO9001, GMP, GLP).

Qualifications

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Life Sciences, or related field.
• Proven experience in a regulated laboratory environment.
• Strong hands-on experience with chromatography techniques (HPLC, UPLC, GC).
• Excellent understanding of ISO9001, GMP, GLP, and laboratory quality systems.
• Experience investigating analytical issues, deviations, and non-conformances.

Responsibilities

• Perform and review chromatographic analyses using HPLC, UPLC, and GC.
• Support QC/QA activities in line with ISO9001, GMP, GLP and regulatory requirements.
• Review analytical data for accuracy and compliance with specifications.
• Lead and support investigations (CAPAs, deviations, OOS/OOT).
• Assist in development, optimization, transfer, and validation of analytical methods.
• Ensure data integrity and adherence to quality standards.
• Maintain instruments and coordinate calibration/maintenance.
• Prepare and review technical reports, SOPs, validation protocols, and quality docs.
• Support internal and external audits and regulatory inspections.
• Drive continuous improvements in lab and quality systems.

Skills

HPLC

UPLC

GC

Data analysis

Quality systems

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences/Life Sciences

Tools

HPLC systems

LC-MS

Job description

Company Description

ChromaGenix supports biopharma innovators in overcoming complex drug development challenges by enabling more efficient, consistent, and scalable purification of advanced biologics such as AAVs, mRNA, and viral vectors. The company specializes in synthetic affinity ligands and chromatography resins engineered for the production of advanced therapies. ChromaGenix partners with teams working on gene therapy, vaccines, and emerging modalities to solve critical downstream processing issues. The organization is driven by a culture of innovation, integrity, and scientific rigor, offering a collaborative environment for scientists who want to contribute to next-generation therapeutics.

Role Description

The Quality Scientist will primarily focus on supporting the establishment of a dedicated quality control function at ChromaGenix, working with the R&D and quality teams to focus on analytical support, method development and validation for our peptide ligand technology and finished products.

Whilst we are seeking a chromatography specialist who has extensive experience in GC, LC, LC-MS and/or FPLC to support the characterization of our peptides which are the basis of our products alongside routine batch release testing.

The role would also require supporting the wider lab team as we also produce our own internally produced feed streams encompassing both AAVs and IgGs which require characterization.

The role would ideally suit a person who has experience in a quality lab in both regulated and non-regulated environments and wants to be part of building a quality control function from the ground up.

Key Responsibilities

• Perform and review chromatographic analyses using techniques such as HPLC, UPLC, and GC.


• Support quality control and quality assurance activities in accordance with ISO9001, GMP, GLP, and regulatory requirements.


• Review analytical data for accuracy, completeness, and compliance with established specifications.


• Lead and support laboratory investigations, CAPAs, deviations, OOS (Out of Specification), and OOT (Out of Trend) investigations.


• Assist in the development, optimisation, transfer, and validation of analytical methods.


• Ensure laboratory activities comply with data integrity requirements and company quality standards.


• Maintain analytical instruments and coordinate calibration, qualification, and preventative maintenance activities.


• Prepare and review technical reports, SOPs, validation protocols, and quality documentation.


• Support internal and external audits and regulatory inspections.


• Drive continuous improvement initiatives within laboratory and quality systems.

Essential Qualifications and Experience

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.


• Proven experience working in a regulated laboratory environment.


• Strong hands-on experience with chromatography techniques, particularly HPLC, UPLC, and/or GC.


• Excellent understanding of ISO9001, GMP, GLP, and laboratory quality systems.


• Experience investigating analytical issues, deviations, and non-conformances.


• Strong data analysis and problem-solving skills.


• Excellent attention to detail and commitment to quality.


• Effective written and verbal communication skills.

Desirable Qualifications and Experience

• Experience within pharmaceutical, biotechnology, medical device, or contract testing laboratories.


• Knowledge of ICH guidelines and method validation requirements.


• Understanding of data integrity regulations, including ALCOA+ principles.


• Previous experience supporting audits and regulatory inspections.