Quality Control (QC) Laboratory Manager

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.

Annual Salary Range: $102,500.00 - 227,700.00.

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.