Process SME

1 week ago

Maryland Line, United States QCS Staffing Full time
Process SME - Life Sciences - Washington DC - 12-Month Contract

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Process SME to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide - and this is your opportunity to be involved

Responsibilities:
  • Become an expert on the process and equipment to successfully lead and implement process improvements
  • Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work
  • Identify and execute projects to increase safety, reduce product cost, improve product quality, improve yield, and reduce material usage
  • Work on several different projects and be able to prioritize these projects
  • Works with contractors and project teams on buildout and expansion of facility while demonstrating confidence in voicing concerns and driving the project team to deliver a usable product for the end internal customer
  • Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, alarm points, and automation strategy
  • Authors, updates, reviews, and approves area procedures and master batch records to ensure correct content and compliance with Good Manufacturing Practices
  • Designs studies, executes experiments and perform data analysis
  • Writes study proposals, progress reports, development reports, and various technical memo’s
  • Evaluates new technologies to improve the commercial production process
  • Supports scale up activities from R&D to production
  • Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch.
Requirements:
  • Bachelor of Science degree in Chemical Engineering or other related technical discipline with direct chemical processing experience preferably in a pharmaceutical production environment.
  • Experience within Cell-Therapy highly preferred
  • Ability to read P&ID’s, Process Flow Diagrams, and perform mass and energy balances.
  • Excellent verbal ,written, and interpersonal communication skills are essential.
  • Displays a high desire to learn while recognizing one’s own limitations.
  • Able to demonstrate technical capabilities using logical thought processes to analyze information and draw conclusions.
  • Experience with bioreactors, Cell Separation Equipment, Flow Cytometers, and other Cell-Therapy equipment
  • Experience with root cause investigations
  • Lean certification or experience with lean concepts
If this role is of interest to you, please apply now #LI-NR1

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