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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.
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