Responsibilities: Support the Lead Data Manager across one or more clinical studies. Reviews protocols for appropriate data capture including electronic (eCRF) design. Support CRF design, review, and validation of clinical database. Pr...
Responsibilities: Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development. Support development including planning, comm...
Responsibilities: All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included...
Responsibilities: Analyze current manufacturing processes to identify areas for improvement. Develop and implement process improvements to enhance efficiency, reduce costs, and improve product quality. Design, select, and install manufac...
Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strat...
priorities and strategies as necessary. Requirements: Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences...
Responsibilities: Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mit...
Responsibilities: Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.). Execute commissioning and qualific...
Responsibilities: Execution of rodent and human ex vivo whole blood or PBMC assays. Tissue mRNA and protein isolation. Perform assays to evaluate target biology and potential therapeutic agents using technologies like qPCR, MSD, Luminex...
Responsibilities: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, E...