Senior CMC Statistician

Ready to engineer precision in the world of biotech? Join our client’s cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow’s breakthroughs.

R&D Partners is seeking a Senior CMC Statistician to support the statistical analysis and evaluation of data for manufacturing processes. You will collaborate with teams to design experiments, analyze data, and provide insights to optimize vaccine manufacturing and analytical methods. This role involves contributing to regulatory submissions and ensuring compliance with industry standards.

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Work with manufacturing teams to set clear goals and success criteria for process studies.
• Design and analyze experiments to improve and validate manufacturing processes.
• Support scale-up, technology transfer, and comparability studies with sound statistical methods.
• Analyze stability and shelf-life data using appropriate models and techniques.
• Implement ongoing monitoring systems to ensure quality and process consistency.
• Investigate and resolve issues using data analysis and root-cause identification.
• Provide practical recommendations for process improvements and control strategies.
• Prepare clear and accurate documentation for regulatory purposes.

Key Skills and Requirements:

• Background in statistics or a related field with relevant experience in industrial statistics and data analysis.
• Experience supporting Chemistry Manufacturing and Controls (CMC) activities, including stability studies and process validation.
• Familiarity with Bayesian statistical methods and advanced statistical software (e.g., SAS, R, JMP, Minitab).
• Knowledge of vaccine manufacturing processes, including cell culture, fermentation, and analytical methods.
• Proficiency in designing experiments, analyzing variance, and implementing process controls.
• Strong communication skills to explain statistical concepts to non-experts and influence decisions.
• Ability to manage multiple projects and deliver results effectively.

Compensation:

• $127,000 to $150,000 per annum.

For more information, please contact Jack Gordon.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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