Quality Control (QC) Laboratory Manager

Description

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.

Qualifications

Required:

Bachelor of Science Degree or Masters 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.

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