Associate Scientist, Quality

Job Category: Quality - Control/Assur/Regul

Requisition Number: ASSOC
003947

• Posted :
  October 15, 2026
• Full-Time

Showing 1 location

Rockville, MD 20850, USA

POSITION SUMMARY:

An Associate Quality Scientist is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. An Associate Quality Scientist will play a critical role in addressing failing product, documenting failures appropriately and determining an appropriate path forward. This position may supervise the work of others directly and/or across interdisciplinary teams.

• 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.
• 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 be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.).
• Establishes and monitors direct report performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides 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 Standard Operating Procedures (SOPs), Test Records, and product specification documents, as required.
• Participate in general lab organization including inventory and equipment management and support 5S compliance.
• Ensure application of laboratory safety precautions and proper use of personal protective equipment.
• Specific duties may vary based on departmental requirements.

• Bachelor’s degree and 2 years of experience in relevant field is required.
• Additional education may be substituted for experience.
• Additional experience may be substituted for degree.

• Strong understanding of protein-based immunoassays and technique.
• Knowledge of protein-based immunoassays execution, development, and optimization is preferred.
• 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.
• Knowledge of Design of Experiments (DOE) is preferred.
• Execute solutions to improve product performance and articulate solutions 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 with demonstrated knowledge and 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 are required.
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
• Proficiency in MS Office suite.
• Basic knowledge of standard data analysis tools and databases.
• Familiar with Matlab, Mini Tab or other statistical software analysis tools is preferred

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.