Scientist II, Quality Control

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.

Education

Required Experience

Salary Range

• Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $124,000-$165,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
• At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune