Scientist I/II,QC Analytical

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 I/II, QC Analytical 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 junior QC staff and provide training for new analyst. The QC Analytical Scientist will be responsible for assisting with maintaining systems for QC Analytical Laboratory. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs). The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that the QC Scientist will maintain 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 Analytical Scientist include, but are not limited, to the following:

• Establish, revise and maintain procedures for QC Analytical testing.
• Maintain QC systems related to raw materials, in-process, drug substance and final drug product 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.
• Perform QC Analytical testing of raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs).
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Responsible for change control, deviations and CAPA’s related to QC Analytical 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 groups to communicate QC Analytical requirements.
• Oversee sampling and storage of QC samples and maintain regulatory/retention inventory.
• Coordinate shipping of samples to contract testing laboratories.
• Train of others within department within the scope of knowledge and responsibilities.
• Understanding of USP/EP monograph testing/requirements.

 

Other responsibilities

• Troubleshoot equipment and analytical test 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 analytical chemistry or other related science, preferably with chemistry or coursework as part of the study program.

Required Experience: 

• 5+ years of experience working in GMP/GLP environment or similar set up.
• Knowledge of Analytical techniques and technical experience, within a Analytical 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 b