Senior Scientist I, Biologics Downstream Commercial Support

Worcester, MA, US
Oct 11, 2018
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated and enthusiastic individual with a passion for commercial scale downstream biologics process support. This position resides in the downstream commercial support group in the Manufacturing Sciences department at the AbbVie Bioresearch Center located in Worcester, MA. The responsibilities presented below require a knowledgeable, goal-oriented, multi-talented individual with very strong scientific, technical writing and communication skills. The candidate must be able to manage several projects simultaneously in a dynamic project landscape.
Key Responsibilities

  • Support downstream commercial manufacturing processes
    • Ensure processes meet quality, productivity and financial targets
    • Provide on-the-floor manufacturing support
    • Identify, interpret and propose responses to out-of-trend (OOT) and non-conforming events
    • Troubleshoot problems, including investigation support
    • Communicate the status of manufacturing campaigns, including presentation of complicated, sensitive information to multiple functional areas Identify, justify and implement process improvements
    • Maintain process databases
    • Assist with the identification and implementation of improved data collection and data analytics methods
    • Prepare assigned sections of annual regulatory reports, and assist in responses to regulatory agency requests
  • Design and perform/manage efficient laboratory scale studies, and analyze and communicate the results, e.g. for troubleshooting technical issues or process improvement purposes
    • Document work in electronic notebook
    • Write clear, concise and accurate technical reports, memos and presentations
    • Help maintain and troubleshoot laboratory equipment
    • Identify and help implement laboratory optimization projects
  • Use established technical transfer processes to successfully transfer, e.g., late stage clinical projects to commercial manufacturing scale, or existing commercial products to other manufacturing plants
  • Devise and implement strategies for process validation lifecycle stage 2 (PPQ) and stage 3 (CPV) activities
  • Author, review and defend relevant CMC sections of regulatory filings
  • Write, maintain and defend process-related, site-wide compliance documents
  • Assist with the development and implementation of innovative technologies in manufacturing

  • BS, MS, or PhD in Chemical or Biochemical Engineering, Biochemistry, or a related field with 10+ years (BS), 8+ years (MS), or 0-3+ years (PhD) of relevant academic and/or pharmaceutical industry experience.
  • Thorough knowledge of protein purification processes (e.g. harvest clarification, chromatography, and membrane-based separations), and experience with their laboratory scale down models, preferably including AKTA chromatography workstations.
  • Working knowledge of relevant statistical techniques, preferably including Design of Experiments (DOE) and Statistical Process Control (SPC)
  • Solid understanding of protein chemistry, including analytical methods
  • Knowledge of CMC regulatory requirements
  • Demonstrated problem-solving skills and ability to resolve complex issues

Key Leadership Competencies

  • Accepts individual responsibility for meeting goals while effectively contributing in a multifaceted team environment (including manufacturing, quality assurance, quality control, CMC/regulatory, engineering, drug product support personnel, management, etc.)
  • Builds strong working relationships across the organization
  • Creates an open learning environment, and embraces the ideas of others
  • Trains and works with junior level scientists and contingent workers, and helps advance their careers

Equal Opportunity Employer Minorities/Women/Veterans/Disabled