Data Reviewer, Analytical Chemistry

Solvias • Morrisville, NC

3d • Onsite

About The Position

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

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

Nice To Haves

• 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.

Responsibilities

• Perform data review for contract services projects. This includes 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 251-500 employees