What are the responsibilities and job description for the QC Scientist position at Replimune, Inc.?
Overview
The Scientist, Quality Control 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 Scientist will be responsible for assisting with the setting up and maintaining systems for QC Analytical Laboratory. The QC Scientist will be required to assist with scheduling, performing and reviewing of tests results of in-process, final drug product and stability samples following established test method (SOPs). The QC Scientist will assist in the management of the QC laboratory and assay transfer from Replimune’s UK facility. It is expected that the QC Scientist maintains GMP compliance in the QC laboratory.
Responsibilities
Key responsibilities:
- Establish, revise and maintain procedures for QC testing.
- Maintain QC systems related to in-process, final drug product and stability sample
- Review testing data of other analysts.
- Assist with the maintenance of QC laboratory and equipment.
- Responsible for the protocol and report generation of assay transfers related to QC tests (techniques such as ELISA, gel electrophoresis, bioassay’s spectroscopy, PCR).
- Perform QC 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 and deviation related to QC operations including assisting with 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 requirements.
- Oversee sampling and storage of QC samples and maintain retain inventory.
- Coordinate shipping of samples to Milton Park and contract testing laboratories.
- Perform QC testing of in-process and product samples following Standard Operating Procedures (SOPs).
- Assist with training of others within department within the scope of knowledge and responsibilities.
Other responsibilities
- Troubleshoot equipment and analytical 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
Educational requirements:
A BA or BS in Chemistry/Biochemistry/Microbiology or other related science
- 3-5 years GLP / GMP experience in a relevant work environment.
Experience and skill requirement:
- Computer literacy (including MS Word and Excel)
- Ability to work well with others
- Effective communication skills
- Good organizational skills
UK Location: Please note that there is a 5 day a week onsite expectation
