Quality Control Scientist - 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.

Join us, as we reshape the future.

Job Summary:

The Quality Control Scientist position is within a small, dedicated Stability team within the wider QC department. The role will be responsible for operational management of Stability studies to support clinical trials and marketing applications. Duties will include generation and maintenance of stability protocols as per ICH guidelines. Managing stability chambers and performing sample pulls in coordination with QC operations, ensuring samples are tested within time point windows and reports are updated/issued. Analysis of data, monitoring of trends and contributing towards shelf-life claims with regulatory documents. The role will involve some laboratory testing although the majority of testing is completed by the dedicated QC operations team.

This role also includes typical operational elements associated with working within a GMP QC laboratory, namely ensuring activities are conducted according to Standard Operating Procedures (SOPs) in compliance with current Good Manufacturing Practices (cGMP). Creating/reviewing, revising SOPs as part of continuous improvement.

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

Responsibilities

• Generation and maintenance of stability protocols as per ICH guidelines.
• Working with QC operations to ensure stability samples are pulled and scheduled for analysis.
• Compile results, perform data trending using appropriate statistical techniques and generate stability reports.
• Maintain operational stability study schedules and produce update reports for management on a regular basis.
• Perform QC testing following Standard Operating Procedures (SOPs).
• Assist with the maintenance of QC stability laboratories and equipment.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports.
• Lead or assist with OOS, OOT, and lab investigations as needed.
• Participate in regulatory inspections and submissions as needed.
• Lead QC Stability equipment introduction and participate in validation activities.
• Interact within internal as well as across other functional groups to communicate QC requirements.
• Manage receipt and storage of stability samples.
• Coordinate shipping of samples to Milton Park.
• Training others within the department for methods and processes according to GMP standards.

Other responsibilities

• Manage technical studies performed to support regulatory submissions.
• Represent QC at inter-departmental meetings, as necessary.

Qualifications

Educational requirements:

• A BA or BS degree in Biological science or equivalent.

Experience and skill requirement:

• Minimum 4 years’ GxP experience in a relevant work environment required.
• Experience within QC laboratory.
• Experience with biologics stability.
• Basic Statistical knowledge.
• Computer literacy (including MS Word and Excel).
• Ability to work well with others.
• Effective communication and excellent organizational skills.
• A positive, can-do attitude.

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.

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