Scientist, Quality

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

1d•$78,100 - $116,200•Onsite

About The Position

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.

Requirements

Bachelor’s degree and 4 years of experience in relevant field is required.
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.
Ability to improve product performance and articulate solutions to broad cross-functional teams.
Demonstrated aptitude for learning and applying new techniques and methodologies.
Strong understanding of basic molecular biology techniques and their application.
Leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes.
Ability to build/foster relationships.
Demonstrated ability to present technical data.
Data integrity understanding and practices.
Ability to prioritize and manage multiple, complex tasks in a fast-paced environment under tight deadlines.
Excellent oral, written communication and interpersonal skills are required.
Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
Proficiency in MS Office suite
Strong knowledge of standard data analysis tools and databases

Nice To Haves

Additional education may be substituted for experience.
Additional experience may be substituted for degree.
Supervisory/management experience desired.
Design of experiments (DOE) is preferred.
Familiar with Matlab, MiniTab or other statistical software analysis tools is preferred.

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.