Associate Scientist Bioscience

2 weeks ago

Frederick, United States Kelly Science, Engineering, Technology & Telecom Full time

Description:


Possesses working knowledge within Bioscience. Delivers experimental work to high standards and carefully adheres to standard operating procedures. Depends on others for instruction, guidance and direction. May be working towards relevant qualification in scientific discipline.


The position combines process validation, data analytics, bioscience, computational science, and technology to determine process robustness and drive high-value insights into developing and enhancing the process monitoring of commercial products. The Scientist delivers process validation protocols and reports to support regulatory filings of commercial products. Additionally, the Scientist develops Advanced Continuous Process Verification (CPV) analytics to support ongoing process monitoring. Analytics includes developing process models to predict process performance as well as providing data summarization and visualization for conveying performance trends to stakeholders. They will also build capabilities for data collation and exploratory statistics related to our strategies. In this capacity, the selected individual will also prepare reports and presentations for relevant partners that provide insights that enable data and science driven decision making.


What you’ll do

  • Author Process Validation and Continuous Process Verification protocols and reports.
  • Partner with Manufacturing Sciences and Technology and Manufacturing teams to develop illustrations and visualizations of data that can easily be comprehended and simplified for non-technical partner audiences.
  • Advise the business on the potential of data, to provide new insights into the business’s mission, and through sophisticated statistical analysis, data mining, and data visualization techniques, to build solutions that enable improved process performance.
  • Partner with Information Technology teams to develop the processes that transform raw data into impactful business insights.
  • Stays abreast of the industry’s trends, to provide forward-thinking recommendations to the business. Strives to build an in-depth understanding of the problem domain and available business data assets, especially those pertaining to critical initiatives and value-based programs.
  • Generates meaningful insights applying statistical techniques, for example, predictive and forecasting statistical models.
  • Responsible for enabling analytical capability to query the data and address various business needs.


Essential for the role

  • Bachelor’s degree in Biosciences or any other related quantitative field. Working experience of the equivalent is also acceptable for this position.
  • Ability to apply data science experience to analyze and interpret biotechnology data.
  • Experience working in probability and statistics, time-series analysis, as well as experience in the use of machine learning methods, for example, linear regression, correlation, statistical significance, etc.
  • Demonstrated track record of working cross-functionally with team members with scientific, industrial and/or commercial expertise.
  • Understanding of modern Information and Digital technologies.
  • Ability to build a business case such as return on investment and breakeven analysis.
  • Ability to identify areas for process and systems innovation and implement change that will improve the overall efficiency of the team


Preferred Experience:


  • Data science, data analytics
  • CMC Statistics
  • General knowledge of applied bioscience
  • Masters degree preferred
  • 6-10 years of applied biopharmaceutical experience in MFG, QC, MSAT, Quality

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