Process Optimization Specialist
1 month ago
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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