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Under the supervision of the Director of GMP,Human Gene and Cell Therapy Facility (HGCTF), the QC Laboratory (Lab) Managerwill lead the establishment of HGCTF (cGMP) QC lab including but not limitedto: equipment receipt and installation, lab operations and procedures, gooddocumentation practices and data management, hiring and training of QCanalysts. The QC Lab Manager will develop, implement and maintain a robusttraining program for QC staff, and ensuring HGCTF QC lab is in compliance withapplicable regulations. The QC manager will be responsible for the overallmanagement of all operations related to quality control testing and compliance.
The purpose of the HGCTF is to manufactureclinical grade gene and cellular therapy products for novel patient treatmentsin clinical trials, and to perform scholarly research and development whenappropriate. In this role, you will direct the quality control unit to supportthe establishment (initially) and operation of HGCTF QC laboratory. The QClaboratory will perform analytical testing of starting materials, in-processsamples, and release testing of drug substance and drug products. The QC labstaff will also perform routine environmental monitoring of the facility cleanrooms and associated space. The QC Lab Manager will be responsible fordeveloping and/or assessing compendial and non-compendial methods for testingof products manufactured/prepared at the HGCTF. These methods may betransferred from research laboratories to the HGCTF QC lab for implementation.The QC Lab Manager will oversee technology transfer, method development,qualification/ validation and/or verification as per applicable guidelines.
The QC Lab Manager will work closely with othermanagers within the HGCTF and will help develop, implement and maintaineffective training programs. The QC Lab Manager will stay current onpublications released by USP, FDA and other pertinent regulating bodies toensure the QC lab and associated activities throughout the facility arecompliant and continuously improved upon.
The incumbent exercises judgment within definedprocedures and policies to determine appropriate action, supervises staff toassure accountability and stewardship of department resources (operational,financial, and human), and directs the QC lab unit and QC support functions incompliance with departmental goals and objectives. A combination of analytical,communication and reasoning skills to accurately and efficiently establish therequired infrastructure and run a QC lab is a must.
Salaryoffers are determined based on various factors including, but not limited to,qualifications, experience, and equity. The full annual salary range for thisposition is $95,900.00- $222,100.00.
Required:
Full Time
$114k-146k (estimate)
06/27/2024
08/25/2024
The job skills required for Quality Control (QC) Laboratory Manager include Quality Control, Leadership, SOP, Installation, Interpersonal Communication, Standard Operating Procedures, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Control (QC) Laboratory Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Control (QC) Laboratory Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Control (QC) Laboratory Manager positions, which can be used as a reference in future career path planning. As a Quality Control (QC) Laboratory Manager, it can be promoted into senior positions as a Construction Inspection Services Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Control (QC) Laboratory Manager. You can explore the career advancement for a Quality Control (QC) Laboratory Manager below and select your interested title to get hiring information.