Principal Research Scientist I - Biologics Drug Product Development
Core
Lead external drug product development activities for biologics (antibodies, ADCs) by serving as the primary technical interface between AbbVie and external CDMOs, ensuring successful execution of formulation and process development.
Role type
Senior IC Principal Scientist (Biologics Drug Product Development)
Builds
Drug product formulations and manufacturing processes for biologic therapeutics
Domain
Biopharmaceuticals / Biologics
Required skills
Formulation principles, drug product degradation pathways, lyophilization, characterization approaches, DOE (JMP/Design Expert), CDMO oversight, technology transfer, investigation resolution, project leadership, stakeholder management
Preferred skills
Protein characterization (SEC, CE-SDS, icIEF, HIAC, MFI, DLS), cross-functional team leadership without direct authority
Technologies
JMP, Design Expert, SEC, CE-SDS, icIEF, HIAC, MFI, DLS
Responsibilities
Serve as primary technical liaison between internal DPD and CDMOs; Lead external development activities including formulation, process development, and tech transfer; Oversee CDMO execution of studies and data packages; Review and provide scientific input on study designs and protocols; Coordinate communication and information flow between CDMOs and internal stakeholders; Drive action-item tracking, risk management, and issue escalation; Ensure functional alignment on Statements of Work (SOWs) and operational activities; Provide technical leadership in resolving issues at external sites.
Seniority
Principal, hands-on IC with strategic oversight
