Replimune
Senior Quality Control Analyst
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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.
At Replimune, we live by our values:
- United: We Collaborate for a Common Goal.
- Audacious: We Are Bold.
- 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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact the lives of patients, caregivers, and themselves.
Join us, as we reshape the future.
Summary of Job Description
The role is responsible for performing the routine and non-routine QC testing following Standard Operating Procedures (SOPs) and established test methods, conduct laboratory-based activities such as reagent preparation, tissue culture, equipment maintenance, sample receipt and disposal, etc. It also involves other QC tasks such as maintaining sample/reagent/consumable inventory and ordering reagents, writing and updating documents, supporting transfer of new methods, and supporting audits and inspections.
This position is based in our Milton Park location and typically has a 5-day on-site expectation.
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Key Responsibilities
- Perform QC testing of various routine and non-routine samples according to Standard Operating Procedures (SOPs).
- Maintain various cell lines on a regular basis by revival and passaging at set intervals.
- Perform QC sample and material receipt and maintain inventory.
- Routine equipment maintenance and troubleshooting as required.
- Lead introduction of new equipment and participate in validation activities.
- Write, update, or review SOPs, protocols, FORMs, and update as required.
- Participate in QC method transfers, validation, and stability activities.
- Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).
- General lab tasks such as housekeeping, inventory of supplies, order supplies, etc.
- Write deviations/CAPA/Change controls related to QC and assist with investigations related to OOS and OOT results.
- Become a trainer in methods as processes and train junior members of the team as required.
- Assist with internal and regulatory agency audits / inspections.
- Ensure training is kept in GMP compliant state.
Educational Requirements
- Degree in Chemistry/Biochemistry/other related science.
Experience and Skill Requirements
- 3 years or more of laboratory-based experience working in a similar environment.
- Competent analytical skills and attention to detail.
- Understanding of GMP requirements.
- Computer literacy (including MS Word and Excel), good communication, and organizational skills.
- Ability to work independently and with others in a team.
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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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