Process Optimization Specialist

1 month ago


Parsippany, New Jersey, United States LeadStack Inc. Full time
Job Title - Process Monitoring and Data Analytics

Location - Hybrid - Onsite T/W/Th

Duration: 12 Months Contract

PR: $50/hr - $70/hr

Key Responsibilities:

  • Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
  • Support batch processing data collection and verification activities.
  • Identify and implement improvements for data collection and management to enable quick and reliable data analysis.
  • Provide statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
  • Assist in resolution of investigations doing statistical analysis.

Requirements:

  • 4+ years of relevant experience and a BS degree in a relevant scientific discipline.
  • 2+ years of relevant experience and an MS degree in a relevant scientific discipline.
  • Strong background in statistics, process monitoring and advanced statistical data analysis.
  • Excellent technical writing skill.
  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
  • Excellent troubleshooting skills and ability to solve complex technical issues.


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