Senior Analyst, Quality Control in Abingdon

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 patient’s 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. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards programme, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients. Join us, as we reshape the future.

Job Summary: The role is responsible for performing the routine and non-routine QC testing following Standard Operating Procedures (SOPs) and established test methods, conduct laboratory-based activities such as reagent preparation, tissue culture, equipment maintenance, sample receipt and disposal etc. It also involves other QC tasks such as maintaining sample/reagent/consumable inventory and ordering reagents, writing and updating documents, supporting transfer of new methods and supporting audits and inspections.

Responsibilities:

• Perform QC testing of various routine and non-routine samples according to Standard Operating Procedures (SOPs).
• Maintain various cell lines on a regular basis by revival and passaging at set intervals.
• Perform QC sample and material receipt and maintain inventory.
• Routine equipment maintenance and troubleshooting as required.
• Lead introduction of new equipment and participate in validation activities.
• Write, update or review SOPs, protocols, FORMs and update as required.
• Participate in QC method transfers, validation, and stability activities.
• Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).
• General lab tasks such as housekeeping, inventory of supplies, order supplies etc.
• Write deviations/CAPA/Change controls related to QC and assist with investigations related to OOS and OOT results.
• Become a trainer in method as processes and train junior members of the team as required.
• Assist with internal and regulatory agency audits/inspections.
• Ensure training is kept in GMP compliant state.

Qualifications:

• Education: Degree in Chemistry/Biochemistry/other related science.
• Required Experience: 3 years or more of laboratory-based experience working in a similar environment.
• Competent analytical skills and attention to detail.
• Understanding of GMP requirements.
• Computer literacy (including MS Word and Excel), good communication and organisational skills.
• Ability to work independently and with others in a team.

About Replimune: Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximise immunogenic cell death and the induction of a systemic anti-tumour immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumour resulting in the release of tumour derived antigens and altering of the tumour microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.