Head of Quality Control
Houston,Â TexasÂ orÂ London,Â UK
Job Title: Head of Quality Control
Responsible to: Chief Operating Officer
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.
- 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 Medicaâ€™s cell therapy products
- Establish specifications and testing process of raw
- 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+ yearsâ€™ 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
- 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.
- Strong project management skills superb organizational, analytical, and communication skills and â€œdo-what-it-takesâ€ 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
This job description is subject to change at any time.
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