Principal Research Scientist I, 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 I, Analytical Lead (R&D)
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
Analytical method development and validation, Project management of analytical development, Regulatory document authoring (INDs/IMPDs), Data interpretation (release, stability, characterization), Third-party lab management, Budget planning
Preferred skills
Experience with multi-specifics, mAbs, ADCs, and fusion proteins, Knowledge of global regulatory requirements (ICH, FDA, EMA), Statistical analysis and Design of Experiments
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, CQAs, and stability plans; Translate strategy into work packages for internal teams; Manage third-party laboratory work; Interpret data trends across assays; Author regulatory submission documents and responses to health authority queries; Present project updates to management and teams.
Seniority
Principal, hands-on IC with strategic ownership
