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.

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United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

Dedicated: We Give Our Full Commitment.

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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 tocontribute 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.

Responsibilities

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 contract testing lab, equipment maintenance and calibration, inventory control, order supplies, periodic review of equipment usage logs.
• Write/review SOPs/summary and trend reports as necessary.
• Establishing and maintaining procedures for QC testing.
• Managing the QC laboratory set up and equipment validation.
• Responsible for the protocol and report generation of assay transfers related to QC tests (techniques such as ELISA, bioassay's, gel electrophoresis, spectroscopy, PCR).
• Oversees external vendors / contract testing facilities for QC testing needs and provides technical support.
• Responsible for executing stability programs for product and key raw materials.
• Manage the system critical reagents
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Responsible for change control and deviations related to QC operations including assisting with laboratory and OOS, OOT, and lab investigations.
• Author QC regulatory documentation and assist in regulatory audits/inspections, as needed.
• Interact within internal as well as across other functional group to communicate QC requirements.
• The safe operation of the QC laboratories at the Milton Park site.
• Develop and maintain a culture of continuous improvement within the QC team.
• Develop and maintain KPIs, monitor performance of the QC Laboratory Operational group and drive demonstrable improvements.
• QC representative for cross functional meetings / projects with manufacturing, QA, Regulatory Affairs, and external partners. Will represent QC during regulatory inspections.

Other responsibilities

• Troubleshooting of equipment and QC methods.
• Manage / perform assay validation and qualification, as necessary.
• Manage technical studies performed with external companies with provision and review of reports.

Qualifications

Education:

• BA or BSc in Chemistry/Biochemistry/Microbiology or other related science.

Required Experience:

• 10+ years GLP/GMP experience in a relevant work environment and 3-4 years of management experience in a GMP-regulated environment.
• Good analytical skills and technical experience is a must, preferentially with previous experience in product and/or raw materials testing.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others.
• Effective communication skills
• Good organizational skills

AboutReplimuneReplimune Group, Inc., headquartered inWoburn, 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 maximize immunogenic cell death and the induction of a systemic anti-tumor 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 tumor resulting in the release of tumor derived antigens and altering of the tumor 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.

We are an Equal Opportunity Employer.