Analyst, CBBA at Solvias in Morrisville, NC

ANALYST, CBBA Location: United States Position Overview Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Senior Analyst position will be one of the primary lab analysts for the CBBA team supporting CBBA and Enzyme-Linked Immunosorbent Assays (ELISA). This position is a team member in the Large Molecule & Advanced Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.  Critical Performance Areas 1. Perform quality lab activities according to assigned schedule. 2. Process samples for release and stability testing, including complex sample preparation, according to GMP requirements. 3. Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP requirements. 4. Support development and validation of CBBA and ELISA. 5. Generate, perform data analysis, and interpret data for assays as needed.    Essential Job Functions • Ability to execute protocols ensuring compliance with GMP regulatory requirements and SOPs.  • Demonstrate good pipetting skills and aseptic techniques in the lab. • 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. • B.A/B.S. in Life Sciences with 2+ years relevant experience.  • Experience working in GMP or GLP environment is preferred. • Experience in assay development, qualifications, validation is a plus. Proficiency in the following areas is preferred: • ELISA • Cell culture • Aseptic techniques • Flow cytometry • Cell based bioassay • Prior CRO/CDMO experience is strongly preferred. • Experience in release testing, supporting method development, qualification, and validation of CBBA and ELISA is encouraged. • Other Desired Skills/Abilities • Excellent organizational skills, ability to work independently and collaboratively in a team environment. • Strong written and verbal communication skills. • Experience with different cell cultures and plate-based assay 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.   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