Associate Director, QC Stability
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 be responsible for overseeing routine and non-routine stability studies.This position will also drive continuous improvement and able to support compliant testing applications for marketing approval and commercial supply.
The Associate Director, QC Stability will work closely with the QC team and is responsible for stability testing and studies to support regulatory applications in support of clinical production and commercial supply. Additional studies will also be required to be managed in support of regulatory submissions i.e. product stability, container closure, accelerated and leachables/extractables testing.The Associate Director, QC Stability will provide technical expertise for laboratory investigations and follow through on close out actions. This position 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:
Key responsibilities:
The Associate Director, QC Stability will be responsible maintaining compliant systems for Stability and provide technical expertise for investigations and regulatory submissions. The responsibilities of the Associate Director QC Stability include, but are not limited, to the following:
- Recruitment, leadership and direction of the QC Stability team at Replimune, Milton Park
- Management and maintaining 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.
- Establishing and maintaining 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 support and ensure acceptably low invalid rate, where problems are identified proactively find suitable solutions and implement appropriate actions to drive continuous improvement.
- Oversees external vendors / contract testing facilities for QC Stability testing needs and provides technical support.
- Responsible for creating and supporting execution of stability programs for product.
- 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 group to communicate QC requirements.
- Represent QC at inter-departmental meetings and interact with external vendors.
- 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.
- 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:
- 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. 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 www.replimune.com.
We are an Equal Opportunity Employer.