Scientist, Analytical Ops
Core
Design and execute extractables and leachables (E&L) studies to support injectable biological drug products, container closure systems, and medical devices.
Role type
Senior analytical scientist (E&L & impurity characterization)
Builds
Injectable biological drug products, container closure systems, and medical devices
Domain
Pharmaceutical manufacturing / Analytical chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Extractables and leachables (E&L) study design and execution, Analytical method development and validation, Trace-level quantification, Structural elucidation, Regulatory compliance (USP, FDA, EMA, ICH, PQRI), Cross-functional collaboration
Preferred skills
PhD in Analytical Chemistry or Pharmaceutical Sciences, Expertise in trace-level impurity detection, Experience with structural characterization and compound identification, Track record of scientific publications
Technologies
GC-MS, Headspace, Direct Inject, LC-UV/MS, LC-MS/MS, High-Resolution Mass Spectrometry (HRMS), ICP-MS, Solid-phase extraction (SPE), Liquid-liquid extraction (LLE), Protein precipitation
Responsibilities
Design and execute E&L studies for injectable biological drug products, Develop and author E&L protocols, reports, and risk assessments, Conduct analytical testing using advanced instrumentation (GC-MS, LC-MS/MS, HRMS, ICP-MS), Identify and characterize unknown compounds using spectral libraries, Develop and optimize analytical methods for E&L testing, Collaborate with toxicology and device/packaging teams to assess patient risk and establish Analytical Evaluation Thresholds
Seniority
Senior, hands-on IC
