At a Glance
- Tasks: Conduct QC testing and manage laboratory operations to ensure high-quality standards.
- Company: Join Replimune, a pioneering company transforming cancer treatment with innovative therapies.
- Benefits: Competitive salary, comprehensive benefits, and a supportive work environment.
- Other info: Collaborative culture with opportunities for personal and professional growth.
- Why this job: Make a real difference in cancer care while working with cutting-edge science.
- Qualifications: BA/BS in a relevant science and 4+ years of GMP experience required.
The predicted salary is between 34650 - 42350 £ per year.
Replimune’s mission is to revolutionise cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumour response, boldly transforming cancer care because patients’ lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the centre of everything we do, and when it comes to our employees, we make it personal.
This role includes responsibility for QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP), managing or overseeing the work of more junior QC staff, setting up and maintaining systems for the QC laboratory, assisting with scheduling, reviewing test results, and participating in assay transfer and validation activities. This position is based in our Milton Park location and typically has a 5-day on-site expectation.
Key responsibilities:
- Perform QC testing following Standard Operating Procedures (SOPs).
- Assist with the maintenance of the QC laboratory and equipment.
- Generate protocol and report for assay transfers/validation.
- Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports.
- Lead or assist with OOS, OOT, and lab investigations as needed.
- Participate in regulatory inspections and submissions, as needed.
- Lead QC laboratory equipment introduction and participate in validation activities.
- Interact within internal as well as across other functional groups to communicate QC requirements.
- Manage receipt and storage of QC samples, reagents and maintain retain inventory.
- Coordinate shipping of samples to Milton Park and contract testing laboratories.
- Train others within the department for methods and processes according to GMP standards.
- Become SME/Trainer for method or process and lead troubleshooting or method optimisation as required.
- Line management responsibility for direct reports if applicable.
- Manage technical studies performed with external companies.
- Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
Qualifications
Education: A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
Required Experience: 4 years or more GLP / GMP experience in a relevant work environment. Computer literacy (including MS Word and Excel). Ability to work well with others. Effective communication skills. Good organisational skills.
Scientist I, Quality Control in Abingdon employer: Replimune Group
Replimune is an exceptional employer that prioritises employee well-being and professional growth, offering a supportive work culture where team members can thrive. Located in a cGMP-compliant environment, the Sr. Warehouse & Facilities Technician role provides opportunities for continuous improvement and hands-on experience with materials management and facilities operations. With competitive compensation packages, including performance incentives and comprehensive benefits, Replimune fosters a rewarding workplace for those seeking meaningful contributions in their careers.
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