Head of Quality Control


Houston, Texas or London, UK

Job Title:  Head of Quality Control

Responsible to:  Chief Operating Officer

 

Role

This individual will lead and drive overall QC strategy and management for Cell Medica ensuring required methods are developed, qualified, validated and maintained. This individual will possess a high level of scientific knowledge and innovation and have the capability to lead, structure and set-up the QC department.

 

Responsibilities

  • Drive overall QC strategy and management in partnership with Manufacturing and Research & Development to ensure required methods are developed, qualified, validated and maintained.
  • Develop in-process and final specifications for Cell Medica’s cell therapy products
  • Establish specifications and testing process of raw materials
  • Lead QC to consistently maintain high level of scientific knowledge and innovation while maintaining GMP compliance.
  • Establish strong links with external manufacturing and process development, and validation contractors and closely monitor their QC operations and output.
  • Act in the capacity of technical expert for analytical methodologies to be able to resolve quality control issues and implement timely resolution. Monitor and trend in-process and final product analytical results to support quality improvements and risk management.
  • Lead high performing scientific team members in developing and managing a state of the art GMP compliant Quality Control Laboratory
  • Responsible for chemical, biochemical, biological and microbiological testing including raw materials to be utilized in cell therapy manufacturing, release and monitoring of patient samples
  • Develop and manage QC budget plans, maintenance of testing procedures, assay controls and standards.
  • Accountable for QC personnel staffing, their training and performance consistent with requirements of GMP compliant operations.

 

Education and Experience

  • PhD in cell/molecular biology or associated sciences
  • Experience in gene/cellular therapy field, preferably in a GMP environment, where the candidate has demonstrated leadership in the field of QC and analytical process development and validation
  • 10+ years’ experience in leading/managing teams, in both analytical and quality control operations
  • Experience in analytical method development and validation in a cGMP environment to support clinical and commercial programs
  • Knowledge of the current state of the art in cell product analytical development and instrumentation, developments and future trends in the field.
  • Capability to build a QC department
  • Experience in management of outsourced activities at CMOs
  • Experience in face-to-face communications with regulatory agencies and in-depth knowledge of GMP regulations in the US and/or Europe.

 

Personal Attributes

  • Strong project management skills superb organizational, analytical, and communication skills and “do-what-it-takes” attitude
  • Strong planning and resource management skills in a dynamic project environment
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual able to work with limited direction in a fast-paced, goal-oriented environment
  • Must be able to remain in a stationary position 50%
  • Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.

 

 

This job description is subject to change at any time.


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