Senior Scientist, Analytical Chemistry

Position Overview

JOB DESCRIPTION

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.

Critical Performance Areas

• 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.
• Familiar with analytical techniques such as UPLC/HPLC, CE-SDS, LC-MS, iciEF, compendial testing etc
  
  

Responsibilities

Essential Job Functions

• Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
• Must have background in biopharmaceutical analytical testing, understand cGMP standards.
• Extensive expertise LC-MS, HPLC, and/or UPLC techniques.
• Experience reviewing operational SOPs, technical documents, protocols, and reports.
• Work collaboratively with cross-functional teams.
• Able to work effectively in a fast-paced environment.
• Excellent communication, technical, organizational, and interpersonal skills are essential.
  
  

Requirements

QUALIFICATIONS

• M.S. Life Sciences with 5 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.
• 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/Empower experience is a plus.
• Prior experience with ELN is preferred, not necessary.
  
  

Reporting Structure

This Job Reports To

• Team Lead, Analytical Chemistry
  
  

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.

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.

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