Senior Analyst/Analyst, 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.

Located at our large molecule headquarters in RTP, North Carolina, the Senior Analyst/Analyst position will join the Analytica Chemistry team supporting CGT. This position is a team member in the Large Molecule & Advanced Therapy Medicinal Products Services (AMTP) in a Good Manufacturing Practices (GMP) laboratory environment.

• Perform quality lab activities according to assigned schedule.
• Process samples for testing, including complex sample preparation, according to GMP requirements.
•  Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP requirements.
• Generate, interpret data, and assist with troubleshooting assays as needed.
• Aid in verifying, validating, and transferring analytical methods for the analysis of drugs according to GMP requirements.
• Handle 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 SOPs.
• Collaborate with scientists and team lead to investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events.
• Train peers in the team as needed.
• Contribute to process improvements for effective and efficient workflows in the lab.
• Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams and customers.

Requirements

• B.A/B.S. in Life Sciences with 2+ years relevant experience.
• Experience working in GMP or GLP environment is preferred.
• Experience in compendial qualification, validation, and verification of methods using the following equipment or techniques is encouraged:
  • Raw Materials-related testing, including but not limited to:
    • IR
    • UV/Vis
  • Osmolarity, Osmolality, Appearance Testing, and pH Measurement
  • GC (FID, NPD, ECD, FPD, MS)
  • Molecular weight distribution
  • Auto-titration
  • Ion chromatography
  • ICP-MS
  • HPLC (UV, FLD, RI, MS, ELS, DAD)
• Prior CRO/CDMO experience is preferred.

Other Desired Skills/Abilities

• Excellent organizational skills and ability to work independently.
• Strong written and verbal communication skills.

Reporting Structure

This job typically reports to:

• Senior Scientist, 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.

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