Senior Analyst/Analyst, Physical Chemistry

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Senior Analyst/Analyst position will join the physical 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.

Critical Performance Areas

• 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.

Essential Job Functions

• 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:
  • Osmolarity, Osmolality, Appearance Testing, and pH Measurement
  • HPLC (UV, FLD, RI, MS, ELS, DAD)
  • GC (FID, NPD, ECD, FPD, MS)
  • IR
  • UV/Vis
  • Molecular weight distribution
  • Auto-titration
  • Ion chromatography
  • ICP-MS
• Customer service experience is preferred.

Other Desired Skills/Abilities

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

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