Qulaity Control

Integrity Bio, Inc.

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Location: Ventura County, CA Posted Date: 4/25/2013 Position Type: Full time Job Code: TBD0004 Required Education: Bachelors Degree Areas of Expertise Desired: Analytical Chemistry
Biochemistry
Laboratory
Protein Chemistry
Quality Control

Description

Company is a contract development and manufacturing organization, speacializing in biologics formulation development and drug product manufacturing.  To meet the growing demand on the part of our clientele regarding the outsourcing of projects and technologies, we are seeking candidates with supervisory and/or management experience in CGMP Quality Control.  This position will have direct responsibility for supervision of QC staff, over both their execution of responsibilities and for their maintenance and troubleshooting of QC laboratory equipment and instrumentation.  The QC Manager will also be responsible for overseeing the transfer, qualification, and execution of all analytical technologies in QC, including (but not limited to) HPLC, capillary and gel electrophoresis, spectrophotometry, and microbiological assays.  The QC Manager will also support the design, execution, and reporting of stability studies executed in the QC laboratory.  The individual in this position will serve as the key contact for Company QC with clients and third-party laboratories.
The QC Manager will participate in the strategic and tactical expansion of Companies QC function, including analytical technologies, manufacturing support, and stability program management.  As this position will entail substantial leadership of the QC lab and its employees, candidates will be evaluated for leadership potential in addition to CGMP experience and technical capability.  

Requirements

We are seeking an individual with experience in the CGMP QC testing environment, with preference given to candidates with supervisory or management experience.  Experience in transfer and qualification/validation of analytical methods utilizing all types of technologies is an essential requirement for the position.  Individuals with experience in the analysis of proteins will be given the highest consideration.  Additional consideration will be given to candidates with experience in developing and managing stability programs.
Candidates for the position with a Bachelor’s or Master’s degree in biochemistry, chemistry, life sciences, or a related field, should have a minimum of 8 years of experience in the CGMP environment, while candidates with a doctorate should have a minimum of 4 years of CGMP experience

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