Description

Manage statistical data analysis and process monitoring for commercial biologic products, applying Continued Process Verification (CPV) strategies.

Responsibilities

• Author, review, and approve CPV protocols and reports for Subject Matter Experts.
• Support batch processing data collection and verification activities.
• Implement improvements for data collection and management to enable reliable analysis.
• Provide statistical expertise for global commercial process monitoring in compliance with ICH, QbD, and Health Authority guidelines.
• Assist in resolving investigations through in-depth statistical evaluation of complex data.

Required Skills

• Strong background in statistics, process monitoring, and advanced statistical data analysis.
• Proficiency with statistical tools including Minitab, JMP, Spotfire, and R.
• Experience with regulatory guidelines from the FDA and EMA.
• Ability to manage multiple projects and priorities effectively.
• Strong technical writing and interpersonal communication skills.
• BS degree in a relevant scientific discipline with 4+ years of experience, or MS degree with 2+ years of experience.

Preferred Skills

• Basic programming capabilities in R and Python.
• Working knowledge of GMP and regulatory requirements for biopharmaceutical manufacturing.

Key Skills

Education

Bachelor's degree