Job Description

Overview:

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor 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 center 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 program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

This role includes responsibility of QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The role will be involved in transfer and validation of methods for testing viral products including complex cell based potency assays and have responsibility for method performance on an on-going basis. This position is based in our Milton Park location and typically has a 5-day on-site expectation.
Responsibilities:

Key responsibilities:

Perform QC testing following Standard Operating Procedures (SOPs). Assist with the maintenance of QC laboratory and equipment. Lead method transfer and validation activities including generating transfer/validation protocols, executing laboratory testing and writing report for assay transfers/validation. Maintain various cell lines on regular basis by revival and passaging at set intervals. Review testing data and records of other operators and data verification for reports. 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 group 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. Training others within department for methods and processes according to GMP standards. Become SME/Trainer for method or process and lead troubleshooting or method optimization as required. Line management responsibility for direct reports as required. Assist with internal and regulatory agency audits / inspections and be a subject matter expert (SME)

Other responsibilitiesManage technical studies performed with external companies. Represent QC at inter-departmental meetings and interact with external vendors, as necessary.

Qualifications:

Preferred Educational requirements:

A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.

Experience and skill requirement:

Minimum 6 years of GLP / GMP experience in a relevant work environment. Experience with statistical software (such as JMP) preferred Computer literacy (including MS Word and Excel) Ability to work well with others Effective communication skills * Good organizational skills