Data Reviewer, Analytical Chemistry

Position Overview

Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Data Reviewer position will be in the AC team supporting analytical activities related to large molecules. This position is a team member in the Large Molecule & Advanced Therapy Medicinal Products (ATMP) Services in a Good Manufacturing Practices (GMP) laboratory environment.

Responsibilities

• Perform data review for contract services projects, including GMP testing for qualification/validation, release, and routine stability studies for different modalities.
• Evaluate laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
• Communicate with laboratory staff to proactively address the quality of laboratory documentation.
• Understand principles of the technologies in scope for data review.
• Verify that calculations and documented information are correct, complete, and accurate in accordance with guiding documents and internal procedures.
• Maintain and update knowledge of relevant instrumentation and cGMP standards.
• Contribute to review related feedback, including review group needs, to the functional management.
• Work with functional management to improve review cycle time.
• Familiar with analytical techniques such as UPLC/HPLC, CE-SDS, LC-MS, iciEF, compendial testing, etc. is a big plus.
• Familiarity with CDS system (Empower/Chromeleon) as well as LabWare Electronic Laboratory Notebook functionalities.

Requirements

• M.S. in Life Sciences with 2+ years of relevant experience, or equivalent combination of education and relevant experience.
• Experience working in GMP or GLP environment.
• Experience in method development, qualification, and validation of analytical chemistry assays, particularly large molecule analysis.
• Previous supervisory experience is a plus.

Other Desired Skills/Abilities

• Experience working in a contract (CRO) environment.
• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.

Reporting Structure

This Job Reports To Team Lead, Analytical Chemistry

About Us

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.