Sr. Analyst, Analytical Chemistry

Position Overview

Responsibilities

• Execute routine testing for the analysis of drugs using analytical techniques according to GMP requirements.
• Perform method verifications and method transfers to support project and testing needs.
• 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.
• Manage inventory, order laboratory supplies, and maintain instrument maintenance.
• Work collaboratively with cross-functional teams and customers.
• Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
• Contribute to process improvements for effective and efficient workflows in the lab.
• Train peers and analysts in the team as needed.
• Able to work effectively in a fast-paced environment.
• Create/review technical documents, protocols, and reports.
• Communicate with clients.

Requirements

• M.S. Life Sciences with 2+ 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.

Qualifications

• 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.

Skills

• 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.

About the Role

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