Senior Scientist, Biophysical Characterization/ Analytical Chemistry

Job Description

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. Position Overview

Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Senior Scientist position will be in the BPC 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.

• Develop, validate, and transfer analytical methods for the analysis of drugs using analytical techniques according to GMP requirements.
• Perform quality lab activities according to assigned schedule.
• Collaborate with the director and team lead to train, develop, and coordinate daily laboratory tasks for the team.
• Generate, interpret data, and troubleshoot assays as needed.
• Manage multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients.
• Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
• Prepare and review lab notebooks, protocols, and reports.
• Investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events.
• Train peers and analysts in the team as needed.
• SME in LC-MS, HPLC, and UPLC techniques.
• Contribute to process improvements for effective and efficient workflows in the lab.
• Responsible for maintaining inventory, ordering laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams and customers.

Requirements

• PhD with 5+ years relevant experience, M.S. Life Sciences with 8+ years relevant experience, or B.A/B.S. with 10+ years relevant experience.
• Experience working in GMP or GLP environment.
• Experience in method development, qualification, and validation of LC/MS assays, particularly large molecule analysis
• Experience communicating with clients is a plus. 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.
• Prior Chromeleon experience is a plus.
• Ion Trap LC-MS experience is preferred.

Note: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization. Estimated travel is up to 10% annually as applicable.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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