Director, Quality Control

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.

Join us, as we reshape the future.

Job Summary:

We are looking for a motivated QC Director at our Milton Park site to be part of the QC Leadership team. The successful candidate will have 10+ years GMP experience with at least 3-4 years of management experience in a GMP-regulated environment. Good technical knowledge of PCR, HPLC, impurity and cell based methods is essential. In addition to stability and release testing the team perform method transfer and validation activities and this position must have good knowledge and experience of method transfer/validation.

The Director QC (Milton Park) will be responsible for setting up and maintaining systems for the QC Laboratories at Milton Park and for managing external contract QC testing. The Director QC (Milton Park) will be responsible for overseeing the routine and non-routine activities of the QC Laboratories. A key role of the Director QC (Milton Park) is to ensure that the QC laboratories are operating efficiently, drive continuous improvement and able to support compliant testing applications for marketing approval and commercial supply.

The Director QC (Milton Park) will also deputize for the Senior Director QC as required and represent the QC department at cross functional meetings.

The QC team is responsible for activities that include product testing, in-processing testing, stability testing and studies to support regulatory applications in support of clinical production and commercial supply. The Director QC (Milton Park) will ensure that this work is planned, performed, and reported in an efficient and compliant manner. The Director QC (Milton Park) is responsible for all QC activities, focusing on areas related to timely and compliant release to assure timely supply of product and technical areas such as method validation and regulatory responses.

The Director QC (Milton Park) is responsible for technology transfer of QC assays and validation of test procedures / sites. Additional studies will also be required to be managed and designed in support of regulatory submissions i.e. product stability, container closure and leachables/extractables testing. The Director QC (Milton Park) will provide technical expertise for laboratory investigations and follow through on close out actions.

The Director QC (Milton Park) will be responsible for ensuring all data reports and documentation to support regulatory submissions are available on schedule.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

The Director QC (Milton Park) will be responsible for the Quality Control group at the Milton Park site that performs the routine and non-routine testing in support of the GMP manufacturing facilities. The responsibilities of the Director QC (Milton Park) include, but are not limited, to the following:

• Recruitment, leadership, and direction of the QC team at Replimune, Milton Park
• Design and monitor KPIs for all areas of Quality Control at Milton Park and work collaboratively with QC Framingham to ensure KPIs are consistent and affective across sites.
• Represent the QC function at cross functional meetings/forums and deputise for the Senior Director QC as required.
• Management and maintaining the QC Laboratory including sample management and identification, sending samples to…