Principal Research Scientist II, Analytical Lead, R&D
Core
Own analytical development strategy and deliverables for biologic programs, serving as the primary analytical point of contact for CMC development teams.
Role type
Principal Research Scientist II, Analytical Lead
Builds
Product control strategies, CQA assessments, characterization and comparability studies, release and stability packages, and regulatory submission content for novel biologic therapeutics.
Domain
Biopharmaceuticals / Analytical Chemistry / CMC Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development and validation for protein therapeutics, Project management of analytical development, Regulatory document authoring (INDs/IMPDs), GXP laboratory investigations, Statistical analysis and design of experiments, Cross-functional collaboration
Preferred skills
Experience with multi-specifics, mAbs, ADCs, and fusion proteins, Mentorship of dual-role analytical leads, Budget planning
Technologies
HPLC, capillary electrophoresis, mass spectrometry, potency assays, ELISA, cell-based functional assays, CD, DSC, light scattering, JMP
Responsibilities
Conceive and own analytical development strategy including methods, specifications, and stability plans; Translate strategy into work packages for internal lab teams; Manage third-party laboratory work; Interpret data trends across release, stability, and characterization assays; Author and review regulatory submission documents and responses to health authority queries; Mentor dual-role analytical leads; Compile program-level analytical information into consolidated reporting.
Seniority
Principal, strategy & mentorship