Group Leader - Analytical Development
Core
Lead analytical development for mRNA proteins/mAbs, evaluating and optimizing methods for cell line, upstream, and downstream development to support regulatory filings and product quality.
Role type
Senior IC analytical development group leader
Builds
Analytical methods and reference standards for biologics (mRNA proteins/mAbs)
Domain
Biopharma / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development (SDS-PAGE, ELISA, Western Blot, U/HPLC, CE, cIEF, LC-MS, qPCR, Sanger Sequencing), Laboratory leadership, Team supervision and training, Regulatory compliance (FDA/GMP), Data integrity management, Cross-functional collaboration, Equipment maintenance and calibration
Preferred skills
Experience with product comparability studies, Degradant profile establishment, CQA definition, Document standardization
Technologies
SDS-PAGE, Agarose Gel, ELISA, Western Blot, U/HPLC, CE, cIEF, LC-MS, qPCR, Sanger Sequencing
Responsibilities
Supervise daily team operations including workload management and training, Hire, train, motivate, develop, and evaluate staff, Ensure compliance with federal, state, and local regulations, Oversee maintenance of laboratories, equipment, and EHS standards, Interface with clients and lead responses to inquiries, Provide subject matter expertise and drive continuous improvement
Seniority
Senior, hands-on IC with leadership responsibilities
