Position: Manager, QC Virus Lab
Division: Scientific
Field: Scientific
Location: Gaithersburg
Salary:
Terms: Direct Placement
Hours:

Qualified individuals will manage activities for the QC Virus Lab group in support of virus based products produced in the cGMP facility.  Responsibilities include method development / transfer, assay qualification and validation, in process and release testing.  Test methods primarily include cell based infectivity assays such as TCID50 and virus plaque assays. Also responsible for implementation and maintenance of GMP systems, testing coordination and scheduling, data review and trending, OOS investigations, CAPAs and deviations, drafting and revising SOPs, staff training and development.

 

 MAIN ACCOUNTABILITIES:

•    Manage and perform testing, analysis and reporting.  Must have expertise with virus cell based methods.  

•    Devise, implement and maintain QC programs to ensure reliability of testing procedures, proper function of laboratory equipment, compliance with federal regulations, prepare and maintain applicable records.

•    Qualify and validate test methods.

•    Perform problem solving and troubleshooting; identify and resolve issues

•    Oversee laboratory supply and equipment ordering and maintain ordering within budgetary guidelines. Assure that the equipment are calibrated and qualified to the degree suitable for their intended use.

•    Prepare and review standard operation procedures and department policies.

•    Represent QC department in client and regulatory audits and participate in responses

•    Train staff

 

KNOWLEDGE AND EXPERIENCE REQUIRED:

•    B.A. or B.S. with 7-9 years’ experience in chemistry or biology or related scientific field or an MS degree with a minimum of 5 years’ experience supervising or managing the operation of a GMP or GLP QC laboratory that conducts viral testing.

•    Must have supervisory/management experience in a QC GMP and/or GLP laboratory involving a staff of 1-4

•    Must have strong virus assay experience.  Must have expertise with: cell based infectivity assays and cell culture.  Viruses include AAV, poxvirus and HIV.  

•    Must have experience with qualification and validation of cell based viral assays

Anchor Technical Services frequently updates its job bank with exciting new opportunities. One or more of those opportunities may be right for you. Please feel free to submit your resume so that we may evaluate your qualifications and identify the placement(s) that best suits you.
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