CK Group are recruiting for a QC Manager with Cell Therapy or related experience to join a biotechnology company at their growing site in Stevenage on a permanent basis.
A clinical-stage immuno-oncology company, that have recently embarked on establishing a new cGMP manufacturing operation, to provide manufacturing capacity for Phase 1 and Phase 2 operations, for their novel T cell platform.
To develop, maintain and oversee QC testing operations to support the safe and timely manufacture and release of products under GMP regulations.
Your responsibilities will be to:
- Manage the QC laboratories and personnel involved in testing and release of clinical products and ensure that all necessary testing is carried out in a timely and compliant manner and that testing records are reviewed and approved to support product release.
- Approve or reject, as appropriate, starting materials, packaging materials, intermediates, bulk and finished products and approve specifications, sampling instructions, test methods, procedures and other Quality Control documentation.
- Design and implement assay qualification protocols for in-process and finished product testing and ensure compliance to future ongoing validation activities.
- Develop initial training programs for QC staff and ensure ongoing training programs are delivered to staff as appropriate.
- Support technology transfer programs and QC process improvement initiatives to improve efficiency, reduce lead time and manage costs and support the review of certificate of analysis and reports for review by Quality Assurance.
- Educated to PhD level in biological sciences or a related field plus progressive industry experience in Quality Control in cell therapy or similar.
- Demonstrated experience in the establishment, qualification and validation of assays related to cell therapy product such as flow cytometry and qPCR.
? Demonstrable knowledge and ability to apply GLPs in conformance with EU, FDA and/or ICH standards.
? Outstanding interpersonal communication and organizational skills.
? Established line management and leadership skills with the ability to effectively negotiate and build collaboration amongst individuals.
Entitlement to work in the UK is essential. Please quote reference 51580.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Mary Bolt
- Phone: 01438 743047
- Reference: 51580
Website: CK Group
- Posted: 7th September 2021
- Expires: 5th October 2021