Associate Scientist, Quality

MSD Careers•Rockville, MD

12d

About The Position

An Associate Quality Scientist independently manages testing, technical transfer, and troubleshooting of protein-based immunoassays. The role is responsible for addressing product failures, documenting them appropriately, and determining a path forward. It may supervise others directly or across interdisciplinary teams. The position reviews testing data, analyzes failures and product or process performance trends, conducts experiments, and presents results and recommendations to cross-functional teams, including senior management. It also supports corrective and preventive action documentation, process and product improvements, compliant testing documentation, laboratory organization, and safety practices. Specific duties may vary based on departmental requirements.

Requirements

Bachelor’s degree and 2 years of experience in a relevant field; additional education may substitute for experience, and additional experience may substitute for a degree.
Strong understanding of protein-based immunoassays and techniques.
Knowledge of laboratory safety precautions and proper use of personal protective equipment.
Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis.
Demonstrated aptitude for learning and applying new techniques and methodologies.
Understanding of basic molecular biology techniques and their application.
Leadership skills and knowledge of staff management practices and processes; ability to establish accountabilities and expectations and manage performance to achieve results.
Ability to prioritize and manage multiple complex tasks in a fast-paced environment under tight deadlines.
Excellent oral, written communication, and interpersonal skills.
Ability to communicate issues, problems, and results that affect laboratory data timelines, accuracy, and reliability.
Proficiency in the MS Office suite.
Basic knowledge of standard data analysis tools and databases.
Ability to communicate and exchange information, use equipment necessary to perform the job, and move about the office.

Nice To Haves

Knowledge of protein-based immunoassay execution, development, and optimization.
Knowledge of Design of Experiments (DOE).
Familiarity with Matlab, MiniTab, or other statistical software analysis tools.

Responsibilities

Review testing data and analyze failures, process performance, and product performance trends and monitoring.
Provide descriptive statistical analyses using clear, concise methodologies and ensure data accuracy and validity.
Conduct experiments, summarize results, and present recommendations to cross-functional teams, including senior management.
Lead Material Review Board (MRB) meetings and facilitate discussions.
Initiate, coordinate, and/or serve as technical lead for CAPA documents, including Deviations and Non-Conforming Material Reports (NCMRs).
Establish and monitor direct report performance and development goals; assign accountabilities, set objectives and priorities, and provide continuous feedback and recognition.
Identify process and product improvements using product data and metrics.
Ensure testing and process documentation complies with MSD processes; develop, revise, and implement SOPs, Test Records, and product specifications as required.
Support general laboratory organization, including inventory and equipment management, and 5S compliance.
Ensure laboratory safety precautions are followed and personal protective equipment is used properly.