Associate Scientist, Quality

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

12d•$67,900 - $101,000

About The Position

An Associate Quality Scientist independently manages the testing, technical transfer, and troubleshooting of protein-based immunoassays. The role plays a critical part in addressing failing product, documenting failures appropriately, and determining an appropriate path forward. The position may supervise the work of others directly and/or across interdisciplinary teams. The Associate Quality Scientist reviews and analyzes testing data, investigates failures, monitors process and product performance, and conducts experiments. The role summarizes results and presents recommendations to cross-functional teams, including senior management. It also leads Material Review Board (MRB) meetings and coordinates or serves as technical lead for CAPA documents, including deviations and Non-Conforming Material Reports. The role supports staff performance and development, identifies process and product improvements, and ensures testing and process documentation complies with MSD processes. It develops, revises, and implements SOPs, test records, and product specifications as needed. The position also contributes to laboratory organization, inventory and equipment management, 5S compliance, and laboratory safety.

Requirements

Bachelor’s degree and 2 years of experience in a relevant field; additional education may be substituted for experience, and additional experience may be substituted for a degree.
Strong understanding of protein-based immunoassays and technique.
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.
Ability to execute solutions to improve product performance and communicate them to broad cross-functional teams.
Demonstrated aptitude for learning and applying new techniques and methodologies.
Understanding of basic molecular biology techniques and their application.
Leadership skills and demonstrated understanding 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.

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.
Provide descriptive statistical analyses using clear and concise methodologies, ensuring 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 ongoing 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 specification documents as required.
Participate in laboratory organization, inventory and equipment management, and 5S compliance.
Ensure laboratory safety precautions are applied and personal protective equipment is used properly.