LCMS Lead Scientist

Description

• Sign off on reports and approve raw data.
• Oversee studies and ensure all methods are prepared, validated, executed, and documented to meet regulatory and client requirements.
• Coordinate across internal and external stakeholders, including discussions with regulators for clinical or pre-clinical studies.
• Coach and indirectly guide a team of up to 20 members.
• Act as the primary scientific point of contact for studies.

Requirements

• Knowledge of ICH or 28BMV regulatory guidance protocols and FDA internal standards.
• 2-3 years of LCMS experience.
• LBA (Ligand Binding Assay) experience, including data review/approval, protocol/sample analysis plan development, and method validation readiness.
• Experience with Sciex Mass Spec and analysis software.
• Travel up to 10% for cross-site or client visits.
• B.S. or Masters in Life Sciences (Chemistry, Biology, Biochemistry, etc.).
• Familiarity with LIMS, Nautilus, and Analyst software.
• Experience as a Lead Scientist with 1-5 years (LS1) or 7-9 years (LS2) of experience.
• Full responsibility over the study, with experience in BioA CRO regulated space.
• Must have experience as a Lead Scientist/Responsible Scientist/Principle Investigator in the Bioanalytical sector (GLP or GCP regulations).

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance