Seeking expertise in the identification and evaluation of gene expressed proteins or peptides acting as renal biomarkers to act as the primary contact and principal scientist and lead a small team in the design and development of mechanism of action studies for clinical trials and analyze and interpret data generated from MOA studies.
Additionally, shall lead collaborative efforts for in vitro cell based assays, stem cell differention, and biochemical assays design, development and data ...
Seeking scientist with molecular IVD expertise to optimize, scale up, and transfer nucleic acid based assays (DNA and RNA) from R&D to manufacturing for a novel IVD platform.
Shall:
*** Optimize and Validate molecular assays targeting DNA and RNA
*** Perform Design Verification and Validation Studies
*** Scale up and Transfer molecular IVD assays from R&D into manufacturing
*** Maintain proper ISO and FDA QSR documentation and implementation
Requirements:
*** MS or PhD in relevant ...
Please read the entire job description below and if you are qualified, send your most current resume in a Word document to: [email removed]
PRIMARY FUNCTION: Responsible for the assembly, quality control and dissemination of data and documentation to regulatory agencies and technical areas.
MAJOR DUTIES AND RESPONSIBILITIES: Describe up to five essential responsibilities of this position including significant tasks, responsibilities and projects.
1. Maintain Submission Activity Listing for the ...
Seeking 5+ years of leadership experience in the design, implementation, analysis and interpretation of statistical data gathered throughout the drug development process including discovery, pre-clinical, and clinical activities to support the advancement of novel therapeutics.
Shall:
*** Lead statistical projects supporting drug development and ensure accurate statistical inputs and deliverables.
*** Act as company representative on statistical matters with regulatory authorities and key ...
Focus on developing, revising, and proofing all reports related to the manufacturing of biologics to ensure compliance with applicable regulatory requirements. Establish priorities, deadlines and changes required for technical documents.
Requires a Bachelor’s degree in the life sciences and 2+ years of scientific writing experience.
Familiar with concept of design history files; familiar with documentation control system, such as Agile.
Would you like to join a company that has been voted top ...
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