Associate Principal Scientist, Analytical R&D (GxP Supervisor 2nd Shift)
Core
Scientific and operational supervisor for a team of specialists and scientists supporting GMP analytical activities including cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product during 2nd shift operations.
Role type
Associate Principal Scientist (GxP Supervisor)
Builds
Non-sterile clinical drug substance and drug product pipeline
Domain
Pharmaceutical R&D / Analytical Chemistry
Required skills
Analytical Method Development, Analytical Testing, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cleaning Validations, Drug Development, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Process Development, Process Analytical Technology (PAT), Protein Analysis, Regulatory Compliance Audits
Preferred skills
Managing a GMP analytical lab, IPC, solvent release, lab investigations/deviations, compliance audits
Technologies
LC-MS, HRMS, PAT
Responsibilities
Serve as scientific and operational supervisor for a team of specialists and scientists; Support execution of Good Manufacturing Practices (GMP) analytical activities; Document experiment execution and results following ALCOA+ principles; Provide technical and compliance oversight for lab investigations and deviations; Review and approval of GMP data, analytical reports, and SOPs; Ensure operational excellence and drive process improvements.
Seniority
Senior, hands-on IC with team leadership
