Associate Director, QC Stability

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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.

Job Summary:

The Associate Director, QC Stability will be responsible for setting up and maintaining a compliant stability program and regulatory submissions in a clinical and commercial setting. The Associate Director, QC Stability will oversee routine and non-routine stability studies, drive continuous improvement, and support compliant testing applications for marketing approval and commercial supply.

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

Responsibilities

Key responsibilities:

• Recruitment, leadership, and direction of the QC Stability team at Replimune, Milton Park.
• Management and maintenance of a compliant stability program including sample management, identifying stability studies, authoring stability protocols and reports, and maintaining trending of all stability activities.
• Write/review SOPs/summary and trend reports as necessary.
• Establish and maintain procedures for a compliant stability program in both clinical and commercial settings.
• Managing the stability area including stability chambers set up and equipment validation.
• Lead complex investigations into OOS or OOT results with a cross-functional group of subject matter experts as required.
• Support troubleshooting assays and ensure an acceptably low invalid rate; proactively find suitable solutions and implement appropriate actions to drive continuous improvement.
• Oversee external vendors/contract testing facilities for QC Stability testing needs and provide technical support.
• Responsible for creating and supporting execution of stability programs for products.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Responsible for change control and deviations related to QC Stability 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 groups to communicate QC requirements.
• Represent QC at inter-departmental meetings and interact with external vendors.
• Ensure the safe operation of the QC stability areas 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.
• Capacity planning of the QC Stability group ensuring sufficient resource availability for the execution of the stability program.
• QC representative for cross-functional meetings/projects with manufacturing, QA, Regulatory Affairs, and external partners; will represent QC during regulatory inspections.
• Ensure Stability Areas meet all internal and external safety requirements.
• Line manage the QC Stability team including but not limited to one-to-ones, appraisals, performance management, and personnel development.
• Provide SME input into regulatory submissions.

Qualifications

Education:

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

Required Experience:

• Minimum 6-8 years GLP/GMP experience in a relevant work environment.
• 6-8 years of laboratory-based experience in a testing capacity and 2-3 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.
• Good statistical knowledge including statistical packages such as JMP.
• Computer literacy (including MS Word and Excel).
• Ability to work well with others.
• Effective communication skills.
• Good organizational skills.

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. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.