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GMP Scientist
2 months ago
Job Summary:
CK Group is seeking a highly skilled Cell Therapy Production Specialist to join their team in Cambridge. As a key member of the GMP Production team, you will be responsible for supporting the production of cellular therapy products for clinical use.
Key Responsibilities:
- Perform batch manufacturing of contract manufacturing products to support the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both Specials and as Investigational Medicinal Products (IMPs).
- Work closely with GMP Production Scientists, Quality Assurance Scientists, and other stakeholders to facilitate the efficient delivery of cellular therapy products for clinical use.
- Ensure compliance with GMP regulations and EU regulations for cell and gene therapy products.
- Develop and implement validated Standard Operating Procedures (SOPs) and report on deviations to SOPs.
- Collaborate with cross-functional teams to drive process improvements and ensure seamless product delivery.
Requirements:
- A degree (or equivalent) in a Science or related discipline.
- Experience of cell culture techniques.
- Experience in aseptic manufacturing in a controlled clean-room environment.
- Working knowledge of GMP for ATMPs and EU regulations for cell and gene therapy products.
- Experience in manufacturing cellular therapies or stem cell processing and cell banking.
What We Offer:
Candidates will be part of a dynamic and growing company, with opportunities for professional growth and development. CK Group is committed to providing a supportive and inclusive work environment.
