Scientist, QC Microbiology

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 Scientist, QC Microbiology will perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This role may also include the responsibility of overseeing the work of more junior QC staff. The QC Microbiology Scientist will be responsible for assisting with the setting up and maintaining systems for QC Microbiology Laboratory. The QC Microbiology Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, final drug product and stability samples following established test method (SOPs), as well as Environmental Monitoring (EM) and Critical Utilities (CU) sampling and testing. The QC Microbiology Scientist will assist in the management of the QC laboratory and assay transfer from Replimune’s Framingham facility. It is expected that the QC Scientist maintains GMP compliance in the QC laboratory.

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

Responsibilities

Key responsibilities:

The responsibilities of the QC Microbiology Scientist include, but are not limited, to the following:

• Establish, revise and maintain procedures for QC Microbiology testing.
• Maintain QC systems related to EM, CU, raw materials, in-process, final drug product and stability sample testing.
• Review testing data of other analysts.
• Assist with the maintenance of QC laboratory and equipment.
• Responsible for the protocol and report generation of method qualifications related to QC tests (techniques such as Bioburden, Endotoxin, Sterility).
• Perform QC Microbiology testing of raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs).
• Perform EM and CU sampling and testing.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Responsible for change control and deviation related to QC Microbiology operations including conducting OOS, OOT, and lab investigations.
• Assist with audits and regulatory inspections, as needed.
• Assist with QC laboratory equipment validation.
• Interact within internal as well as across other functional group to communicate QC Microbiology requirements.
• Oversee sampling and storage of QC samples and maintain retain inventory.
• Coordinate shipping of samples to Milton Park and contract testing laboratories.
• Train of others within department within the scope of knowledge and responsibilities.

Other responsibilities

• Troubleshoot equipment and microbiological/biological (e.g. endotoxin) methods.
• Manage technical studies performed with external companies with provision and review of reports.
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
• Other tasks as assigned.

Qualifications

Education:   

• BA or BS in Microbiology or other related science, preferably with Microbiology modules or coursework as part of the study program.

Required Experience: 

• 3-5 years of experience working in GMP/GLP environment or similar set up.
• Knowledge of Microbiology techniques and technical experience, within a Microbiology Lab is preferred.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.
• 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. 

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