Scientist, Quality

Position Summary A Quality Scientist is responsible for independently managing the testing, technical transfer, and advanced troubleshooting of protein-based immunoassays. A Quality Scientist is expected to manage the process of troubleshooting multiple non-conforming products and independently manage multiple high-impact projects to improve product and process quality. This position may supervise the work of others directly and/or across interdisciplinary teams.

DUTIES AND RESPONSIBILITIES

• Review testing data and perform analyses including investigations of failures, as well as process and product performance trending and monitoring.
• Provide descriptive statistical analysis using clear and concise methodologies and ensure accuracy and validity of data.
• Perform data analytics including process and product performance trending and monitoring. Analysis includes identification of process and product improvements.
• Present experimental conclusions, recommendations and proposed initiatives to cross-functional and/or senior management teams.
• Lead Material Review Board (MRB) meetings and facilitate discussions.
• Initiate, coordinate, and/or be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.).
• Establish and monitor staff performance and development goals, assigns accountabilities, sets objectives, establish priorities, and provide continuous feedback and recognition on performance.
• Identify process and product improvements using product data and metrics as a guide.
• Ensure testing and process documentation complies with MSD processes. Develop, revise and implement SOPs, Test Records, and product specification documents, as required.
• Specific duties may vary based on departmental requirements.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree and 4 years of experience in relevant field is required. o Additional education may be substituted for experience. o Additional experience may be substituted for degree.
• Supervisory/management experience desired.

KNOWLEDGE, SKILLS AND ABILITIES

• Strong scientific fundamentals and analytical background.
• Demonstrated understanding of protein-based immunoassays and techniques is required.
• Knowledge of laboratory safety precautions and proper use of personal protective equipment.
• Knowledge of protein-based immunoassays execution, development, and optimization.
• Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis. o Design of experiments (DOE) is preferred. o Ability to improve product performance and articulat