Texas
Fredericksburg, Virginia
Oak Park, Illinois
New York, New York
Allentown, Pennsylvania
Posted: 15-Jul-24
Location: Los Angeles, California
Salary: Open
Categories:
Internal Number: 140055943
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:
- Bachelor of Science Degree or Master's degree in Biology,Chemistry, or related field and a minimum of five years of GMP quality Controlexperience, a higher degree (Ph.D. or Pharm D.) with two years of GMP qualitycontrol experience.
- Two years of managerial experience, directly managing peopleand/or leadership experience leading teams, projects, programs or directing theallocation of resources preferred.
- Experience with qualification, technology and method transfer, andvalidation/verification of analytical methods.
- Knowledge of environmental monitoring in a cGMP setting.
- Working knowledge of GMP requirements and regulations. Previousexperience directly involved with federal regulations regarding GLP and GMP.
- Knowledge of regulatory affairs, quality control and production.
- Knowledge of Standard Operating Procedures and Quality Controlrequirements in a GMP laboratory setting. Experience in writing SOPs anddemonstrated ability to develop and monitor quality improvement plans and SOPs.
- Ability to work flexible hours, various hours on short notice(including covering staff shortages, weekends and holidays); determine workloadpriorities for completion of job assignments in a timely manner to meetcritical deadlines.
- Strong interpersonal communication skills to effectively anddiplomatically interact with physicians, staff, administration & sponsors.
- Supervisory Experience and Management Skills.
