Scientist, Biologics CMC Analytical Development
Core
Lead analytical development for biologics in pre-pivotal stages, defining critical quality attributes and enabling characterization for toxicology and early clinical trials.
Role type
Senior IC analytical scientist (biologics CMC)
Builds
Robust analytical methods and control strategies for therapeutic proteins
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, HPLC-UV/FLR/CAD/ELSD, CE/iCIEF, Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, critical quality attribute definition, control strategy establishment, regulatory compliance (FDA/ICH), data integrity, technical documentation, cross-functional collaboration
Preferred skills
Leading early-stage CMC analytical programs, analytical method qualification/validation, lab automation, computer system validation, knowledge management
Technologies
HPLC, iCIEF, CE, LC-MS
Responsibilities
Define potential critical quality attributes (pCQAs) and establish phase-appropriate control strategies; Design, develop, and deploy robust analytical methods for product characterization and release/stability testing; Evaluate and implement state-of-the-art technologies to enhance analytical capabilities; Provide technical oversight of internal and external analytical activities ensuring data integrity; Partner with Research, Process Development, Clinical Development, Safety, and Program Strategy teams; Present findings to senior leadership and support regulatory submissions (IND/IMPD/CTA)
Seniority
Senior, hands-on IC
