SUMMARY This position will be responsible for activities involving compliance with applicable regulatory requirements and internal policies within the Manufacturing Group. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Performs the compliance review and approval of all manufacturing batch documentation related to disposition of clinical products Author/Review deviations and
Responsible for the implementation of cGMP in the pilot plant. Write and review SOPs and production batch records. Implement production processes for the manufacture of plasmid DNA. Conduct cGMP production of plasmid products on an ongoing basis. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Under direct supervision of the Director of IT, provide prompt and accurate response to and diagnose problems through discussions with end users, research, diagnose and resolve moderately complex technical problems. Respond to requests for technical support as well as document, track, and monitor the problems to ensure a timely resolution.
Job Description: Job Title: Quality Control Associate Status: Full time Department: Operations – Quality Control Reports to: Quality Control Manager Job Purpose: The Quality Control Associate (QC Associate) is a vital position in the quality unit operations of Celltex’s laboratory services. The primary responsibility of the QC Associate is to
Job Description The Regulator Manager reports to the Director of Clinical Operations/QA who bears primary responsibility for managing Formation Biologics obligations as identified for clinical trial management and execution. This position requires project management responsibilities and includes the development of tools to assist in source documentation of clinical trial oversight
Position Description: Manages a laboratory program for one or more biotech instructional laboratories, including supervision of laboratory assistants. Selects, trains and coordinates the work of lab assistants and graduate assistants assigned to the lab. Schedules, monitors and evaluates performance of lab assistants and graduate assistants. Recommends enhancements and revisions of
Description ApoCell is a leading molecular diagnostics company specializing in biomarker development and translational research in the liquid biopsy and immuno-oncology market. We are seeking an outstanding candidate for a key progressive scientific position. This individual will have the unique opportunity to utilize their scientific skills in the environment of
Job Description: ApoCell is a leading molecular diagnostics company specializing in biomarker development and translational research in the liquid biopsy and immuno-oncology market. We are seeking an outstanding candidate for a key progressive scientific position This individual will have the unique opportunity to utilize their scientific skills in the environment