layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Principal Scientist, Analytical Development and QC, Small Molecule at Immunome | LAYIQ

Develop and execute phase-appropriate analytical methods for small molecule Linker payload (LP) intermediate, including specifications and control strategies.
Provide technical leadership for method development, qualification, validation, transfer, troubleshooting, and lifecycle management across various techniques such as LC, GC, LC-MSMS, Karl Fischer, and spectroscopy.
D evelop robust analytical testing methodologies to support complex small molecule manufacturing, characterization, release and stability testing, on-site or in collaboration with Contract Development/Manufacturing Organization (CDMO), Oversee and manage relationships with external testing labs ensuring alignment with project timelines, quality standards, and regulatory requirements.
Lead investigations of method performance, manufacturing issues, deviations, and OOS/OOT results; root-cause analysis, corrective actions, and risk-based recommendations.
Assume Analytical Lead responsibilities for Immunome pipeline programs, providing scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.
Participate in the creation of essential documentation (SOPs, protocols, reports) to support GMP activities, regulatory submissions, and method transfers.
Stay informed of emerging trends in analytical development and evolving regulatory requirements, integrating these into the company’s development and QC strategy.
Work closely with cross-functional teams, including discovery and process chemistry, quality assurance, virtual management team and regulatory affairs to ensure alignment of project goals and objectives.
Author and review analytical sections of CMC documents and regulatory submissions (IND/CTA, NDA/MAA, CTD), including methods, validation, specifications, impurities, and stability. Review batch records and batch release documentation.
Establish analytical and stability plans, impurity-control approaches, reference standard programs, and comparability strategies supporting scale-up and technology transfer.
Assist in establishing internal capabilities for small molecule analytical method development and product characterization.

Principal Scientist, Analytical Development and QC, Small Molecule

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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