Our client is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defense mechanisms, and eliminate these cells. They have a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumours, and autoimmune diseases.
Role Summary:
The post holder will provide Quality Assurance support within the Product Delivery team, helping ensure the compliant and timely delivery of autologous CAR T-cell products in accordance with GMP requirements.
Key Responsibilities:
- Provide day-to-day Quality Assurance support to GMP manufacturing operations for autologous CAR T-cell products
- Review Batch Manufacturing Records, Quality Control records and associated GMP documentation to support timely batch certification and product release
- Manage and coordinate quality events, including deviations, investigations, OOS/OOT results, environmental monitoring excursions, CAPAs and change controls
- Assess quality issues arising during manufacturing, ensuring appropriate investigation, documentation, escalation and resolution
- Act as a key QA point of contact for Manufacturing, QC and other cross-functional stakeholders, escalating significant quality issues to Quality leadership and Qualified Persons (QPs) as appropriate
- Support the maintenance of batch and patient-specific product traceability throughout the manufacturing and release process
- Author, review and approve GxP documentation in accordance with established procedures and regulatory requirements
- Support the effective operation and continuous improvement of the Pharmaceutical Quality System (PQS), ensuring quality activities are progressed and closed within appropriate timelines
- Support regulatory inspection readiness and other QA compliance activities as required
Demonstrated Skills and Competencies
Experience:
- 2-5 years’ experience in sterile manufacturing in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system
Qualifications:
- BSc degree in life sciences (E) or significant relevant industry experience
- MSc in pharmaceutical sciences, immunology or equivalent experience (P)
Skills/Specialist Knowledge:
- Strong working knowledge of GMP principles within a pharmaceutical, biotechnology or cell and gene therapy manufacturing environment
- Experience providing QA support to manufacturing/operations within a GMP facility
- Experience with deviation management and investigations, including OOS results, environmental monitoring excursions, CAPAs and change controls
- Experience reviewing GMP manufacturing documentation and batch records to support batch certification and product release
- Ability to identify, assess and appropriately elevate quality issues to Operations, Quality leadership and Qualified Persons (QPs)
- Understanding of quality requirements associated with patient-specific manufacturing and autologous CAR-T products
- Ability to manage multiple quality activities in a fast-paced manufacturing environment where timely batch disposition is important
- Strong cross-functional communication skills with the ability to work independently and collaborate effectively with Manufacturing, QC and QP functions
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Contact Details:
Skills Alliance Enterprise Recruitment Team
