As part of a talented, dynamic and fast-paced team advancing an exciting novel approach to oncology drug development, the QC scientist will support QC stability testing for antibody drug conjugates.
The candidate will have a primary responsibility in the stability function to initiate new and/or update stability studies as part of the QC organization in support of the company’s timelines and goals. The candidate will perform analytical testing for stability time points, and perform data entry and data verification for stability summary tables and reports. The applicant will also conduct stability sample inventory and pulling of stability time points per study protocols and stability data trending to support retest extension activities. Non-routine testing as part of investigations and method qualification activities in a cGMP environment may also be required. This position requires excellent laboratory skills, great attention to detail at the bench, and excellent documentation practices.
There is opportunity to grow and own projects or processes in areas of analytical method qualification, raw materials, equipment qualifications, etc.
Primary Duties and Responsibilities:
• Responsible for stability studies across all compounds in a compliance with ICH, WHO, company quality guidelines and SOPs in support of the company’s timelines and goals
• Perform stability sample inventory and pulling of stability samples per approved protocols.
• Perform routine stability testing in support of cGMP stability studies.
• Perform non-routine testing as part of the method qualification and optimization activities.
• Trend routine stability data to support product shelf-life and retest extension activities.
• Participate in investigations as part of an OOS and/or troubleshooting of methods and test equipment.
• Support the QC team with routine tests for in-process control and lot release and assist with data review.
• Participate in review and creation of new and existing SOPs
• Have responsibilities in activities related to preventive maintenance, qualification and calibration of stability chambers.
• Share responsibilities with the team to support sample and equipment management.
• Assist in maintaining the QC lab and its systems in a cGMP compliant state.
• Contribute to team building, training and problem-solving initiatives.
• Communicate effectively verbally and in writing.
• Ability to work independently with little or no direct supervision.
• Establish and maintain work schedule goals.
• Good knowledge of statistical interpretation, trending of stability results and cGMP practices
• Ability to multi-task, effectively manage timelines, great attention to detail and team-oriented personality are a must.
• Bachelor's degree in Biology, Chemistry, or other life sciences-related discipline.
• 5+ years pharmaceutical/biopharmaceutical laboratory experience working in a regulated (GMP) laboratory environment, preferably with QC experience
• Demonstrated expertise in analytical techniques such as HPLC, GC, KF, FTIR, ELISA, etc.
• Knowledge of LIMS or stability software is a plus