- Holly Springs, North Carolina, United States
- On-site
- Full-time · Manager
- 5+ years
The Supervisor, QC Chemistry, first shift is responsible for day-to-day supervision, audit readiness, and planning activities for the Chemistry laboratory, leading a team responsible for performing routine testing of QC analytical chemistry methods used in biological product manufacturing.
Responsibilities
- Provide supervision and manage scheduling of the QC Chemistry team to ensure testing timelines are achieved
- Ensure analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations
- Perform, review, and provide expertise in physical and chemical analytical testing methods, including chromatography (HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, ELSD), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, peptide mapping, and physical appearance per Standard Operating Procedures (SOPs) and test methods
- Act as primary point of contact for the team and first-line escalation
- Lead the team to meet project deliverables
Requirements
- Bachelor’s in Chemistry, Biochemistry, Biological Sciences, or related science field
- Master’s in Chemistry, Biochemistry, Biological Sciences, or related science field
- Nice to have: Managing complex projects
- Nice to have: Customer relationship management
- Nice to have: Drug substance or manufacturing experience