• Job Description

  Req#: SCIEN002812

  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 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.
  o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
  • Proficiency in MS Office suite
  o Strong knowledge of standard data analysis tools and databases
  • Familiar with Matlab, MiniTab or other statistical software analysis tools is preferred.

  
  PHYSICAL DEMANDS:
  
  • This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.
  
  WORK ENVIRONMENT:
  
  Standard office environment

  Qualifications

  Education

  Required

  Bachelors

• About the company

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