Role Overview
We are currently looking for a Quality Control and Analytical Development Lead to join a leading advanced therapy company based in London. As the Quality Control and Analytical Development Lead you will be , you will craft and oversee the quality control and analytical development functions at the cutting-edge pilot plant. Your role is crucial in ensuring the safety and conformity of the entire production process, collaborating with a skilled team of food scientists, biologists, and engineers.
Key Duties and Responsibilities
Your duties as the Quality Control and Analytical Development Lead will be varied however the key duties and responsibilities are as follows:
1. Establish and direct the strategic vision for quality control, creating robust workflows to meet stringent standards.
2. Develop and conduct analytical assays, innovate with new equipment and techniques, and manage a dedicated team of analytical scientists.
3. Oversee the in-house QC lab, liaise with external testing labs, and coordinate with satellite QC labs at manufacturing sites, ensuring clear communication of results to stakeholders.
4. Collaborate with the Facilities and Laboratories team to implement a top-tier quality management system, authoring risk assessments, SOPs, food safety plans, and managing essential quality documentation.
Role Requirements
To be successful in your application to this pivotal role as the Quality Control and Analytical Development Lead, we are looking to identify the following on your profile and past history:
1. A PhD in cell biology, microbiology, biochemistry, or proven industry experience in a GLP/GMP cell culture production environment.
2. Extensive experience in quality management, QC/QA, or CMC related to cell culture processes as well as high levels of proficiency in writing quality documentation and reports for regulated products, with a knack for constructing key quality and regulatory plans.
3. A thorough grasp of molecular biology and analytical chemistry assays, such as ELISA, biochemical assays, mass spectrometry, and microbiology.
Key Words: Quality Control / Analytical Development / Food Science / Biotechnology / GLP / GMP / Cell Culture / Quality Assurance / Regulatory Submission / SOPs / HACCP / ISO 9001 / ELISA / Mass Spectrometry / London
