Design, optimize, and execute in vitro and ex vivo immune assays to assess immune modulation, including immune cell activation and suppression using primary and engineered immune cells. Perform multiparametric flow cytometry (e.g., surface ...
Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical development (GLP and non-GLP), including toxicology, bioanalytical, and biomarker data supporting IND, CTA, and NDA subm...
management experience in commercial healthcare organizations (i.e., Biotech, Med Device or Specialty Pharmaceuticals). 3+ years...
End-user Subject Mater Expert (SME) for the Manufacturing Execution System (MES), Real-Time Modeling System (RTMS), and other IT capability systems (such as SAP, LIMS, Infor) that support Norton manufacturing operations, with an initial foc...
and implement sourcing strategy and action plans to support Alnylam's Supplier Diversity and Sustainability initiatives. Build...
Lead the development, selection, and characterization of stable, high-titer cell lines for the production of monoclonal antibodies and antibody-oligo conjugates. Evaluate, select, and manage CDMOs to execute regulatory-compliant cell line d...
Develop and execute population PK, PK/PD, exposure response, disease progression models, dose selection for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies through Phase 3 study ...
Business Development Support & Evaluations: Lead and execute financial evaluations in support of the Business Development organization, including valuation modeling, scenario and sensitivity analyses, and comparable transaction benchmarking...
Develop, calibrate, and validate mechanistic QSP models to describe disease biology, drug mechanism of action, and PK/PD relationships. Integrate diverse data sources (in vitro, in vivo, clinical, omics, literature) into QSP modeling framew...
Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead US HA interactio...