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Associate Director, Qc Stability
2 weeks ago
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**:
- 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.
- 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.
**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**:
- 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**
We are an Equal Opportunity Employer.
