Associate Principal Scientist, Biopharmaceutics
Core
Lead biopharmaceutics strategy for subcutaneously administered biologics, guiding formulation, device, and dose decisions from early development through commercialization.
Role type
Senior IC scientist (biopharmaceutics strategy)
Builds
Biologic drug products for subcutaneous delivery
Domain
Biopharmaceuticals / Drug Delivery
Required skills
Biologics drug product development, Subcutaneous absorption, Translational pharmacokinetics, Formulation characterization, Immunogenicity risk assessment, Matrix leadership, Regulatory submissions, Device transitions, In vitro-in vivo translation, Bridging strategies
Preferred skills
Mechanistic modeling (GastroPlus, Simcyp, PK-Sim), High-concentration SC delivery, Device-biologic interactions, Peer-reviewed publications
Technologies
GastroPlus, Simcyp, Phoenix WinNonlin, PK-Sim, MATLAB, Python, R
Responsibilities
Define integrated experimental and modeling strategies for formulation and device decisions; Translate preclinical findings to support product bridging and scale changes; Evaluate product quality attributes and delivery conditions for immunogenicity and PK impact; Communicate risks and recommendations at governance forums; Mentor scientists and develop predictive tools.
Seniority
Senior, hands-on IC
