Principal Scientist I, Biologics Analytical Research and Development
Core
Scientific leadership in developing advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product development for innovative medicines.
Role type
Principal Scientist, Biologics Analytical Research and Development
Builds
Biotherapeutic protein characterization methods and regulatory submission documents for multi-specifics, ADCs, antibodies, and novel modalities.
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Capillary electrophoresis, HPLC, protein chemistry, biochemistry, analytical method development, QC method qualification/validation, method transfer, regulatory submission writing, technical problem solving, team supervision
Preferred skills
Impurity profiling, protein characterization, cross-functional influence, scientific publications, conference presentations
Technologies
Capillary electrophoresis, HPLC
Responsibilities
Independently develop state-of-the-art capillary electrophoresis and chromatographic methods to characterize biotherapeutic proteins and their associated variants and impurities. Generate new scientific proposals and develop innovative approaches to solve difficult analytical challenges. Represent the Biologics CMC Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross functional project teams. Supervise a team of one or more scientists and be accountable for the effective performance of the team. Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods. Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, and method qualification/validation protocols.
Seniority
Principal, hands-on IC with supervisory responsibilities