Job Abstract

Under the supervision of the Director of GMP, Human Gene and Cell Therapy Facility (HGCTF), the QC Laboratory (Lab) Manager will lead the establishment of HGCTF (cGMP) QC lab including but not limited to: equipment receipt and installation, lab operations and procedures, good documentation practices and data management, hiring and training of QC analysts. The QC Lab Manager will develop, implement and maintain a robust training program for QC staff, and ensuring HGCTF QC lab is in compliance with applicable regulations. The QC manager will be responsible for the overall management of all operations related to quality control testing and compliance.

The purpose of the HGCTF is to manufacture clinical grade gene and cellular therapy products for novel patient treatments in clinical trials, and to perform scholarly research and development when appropriate. In this role, you will direct the quality control unit to support the establishment (initially) and operation of HGCTF QC laboratory. The QC laboratory will perform analytical testing of starting materials, in-process samples, and release testing of drug substance and drug products. The QC lab staff will also perform routine environmental monitoring of the facility clean rooms and associated space. The QC Lab Manager will be responsible for developing and/or assessing compendial and non-compendial methods for testing of products manufactured/prepared at the HGCTF. These methods may be transferred 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 other managers within the HGCTF and will help develop, implement and maintain effective training programs. The QC Lab Manager will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the QC lab and associated activities throughout the facility are compliant and continuously improved upon.

The incumbent exercises judgment within defined procedures and policies to determine appropriate action, supervises staff to assure accountability and stewardship of department resources (operational, financial, and human), and directs the QC lab unit and QC support functions in compliance with departmental goals and objectives. A combination of analytical, communication and reasoning skills to accurately and efficiently establish the required infrastructure and run a QC lab is a must.

Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity. The full annual salary range for this position 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 Control experience, a higher degree (Ph.D. or Pharm D.) with two years of GMP quality control experience.
• Two years of managerial experience, directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources preferred.
• Experience with qualification, technology and method transfer, and validation/verification of analytical methods.
• Knowledge of environmental monitoring in a cGMP setting.
• Working knowledge of GMP requirements and regulations. Previous experience directly involved with federal regulations regarding GLP and GMP.
• Knowledge of regulatory affairs, quality control and production.
• Knowledge of Standard Operating Procedures and Quality Control requirements in a GMP laboratory setting. Experience in writing SOPs and demonstrated 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 workload priorities for completion of job assignments in a timely manner to meet critical deadlines.
• Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors.
• Supervisory Experience and Management Skills.