~~Excellent oppt'y for a Medical Technologist to work for a medical lab manufacturer and utilize their lab knowledge as an Application Specialist. Will be involved with direct problem solving covering reagents, kits, procedures, adaptations, and software upgrades. Will also be instrumental during the installation process as a trainer, and documenting the lab procedures. Represent the company at seminars, conventions, meetings, & wet workshops. Your lab knowledge will also be utilized in Pre & Post ...
Lead a scientific team developing and validating: Array based assays; Gene expression assays; qRT-PCR assays and various similar assays for automated IVD platforms
Shall ensure adherence to protocols and proper documentation for FDA design control through validation and product manufacturing.
At least 5 years relevant experience and a Masters Degree in Genetics, Pharmacology, or Molecular and Cellular Biology or related field required.
Join an organization well established within the medical ...
Responsible for performing quality related tasks and managing multiple quality systems in support of Manufacturing, Process Development, Research, and Laboratory operations. Interpret and ensure compliance to departmental policies and procedures, and manage activities to assure cGMPs and regulatory compliance. Interface with management in order to understand and address any quality or compliance issue.
Quality oversight of manufacturing operations and QC testing activities ...
The Director of Regulatory Affairs will provide Regulatory Affairs Leadership for development teams throughout the development program of the Company’s therapeutic candidate projects. The Director will be fully responsible for the development of efficient and effective regulatory strategies and in the prosecution of those strategies in achieving the commercial status and lifecycle management.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These include, but are not limited to ...
Nov 11 -
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