Biologics developer seeking PhD or MD plus minimum 8 years industrial experience to lead development of translational strategies and identification of drug-related biomarkers and companion diagnostics, for the support of Oncology clinical trials
*** Conceive, initiate, and execute biomarker strategies for Oncology therapeutics in various phases of clinical development.
*** Identify and implement biomarker assays.
*** Analyze drug pharmaco-dynamic data from various ...
Design and implement cross-functional projects related to the research, development, and continuous improvement of Multiplex PCR Assay development pipeline by coordinating application of fundamental biochemical methods, genetics and genomics.
Working closely with bioinformatics, will design assay schemes, define protocols and conduct optimization and validation experiments acting as a project lead.
*** PCR primer, probe and oligonucleotide design and development.
Seeking degree in chemistry, biology, engineering or similar and leadership track record in biological pharmaceutical manufacturing quality compliance who is expertly familiar with biopharmaceutical manufacturing operations, documentation management, training, and auditing.
*** Supervising RA and QA associates and contractors.
*** Oversight of corrective and preventive actions.
*** cGMP and GMP Document management.
*** Coordinating and maintaining cGMP and GMP training program.
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