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Job Description
Job Summary:
Supports the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, data analysis and/or laboratory testing.
The ideal candidate will have experience working in a complex and matrix environment, strong negotiation skills, and technical knowledge in drug product manufacturing, product development, and validation.
Responsibilities:
• Performs verified data entry tasks into electronic systems in a timely and efficient manner
• Tracks cycle time and metrics for data entry process
• Supports the implementation, expansion, and continuous improvement of Regeneron's Application for Data Aggregation and reporting system
• Manages quality system events pertaining to data integrity and data management such as investigations, CAPAs, Change Controls, and general document approvals
• Tracks trending process performance to establish/improve process capability, uses data analytics and/or laboratory testing to develop metrics and ensures process is operating within intended process control strategy
• Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities
• Leads efforts associated with the drug product Continued Process Verification (CPV), documentation, and trending of In Process Control (IPC) initiative
• Maintains required training status on Regeneron specific work instructions and SOPs
• Collaborates with cross-functional teams to define and execute drug product process development and technology transfer activities
• Collaborates with peers, procures, implements, and evaluates new technologies for potential future use in the drug product process
• Maintains an awareness of relevant equipment and technology vendors, their existing and planned offerings, and their anticipated performance
• Supports process investigations and assists with product impact assessment for change controls and internal/external investigations, through laboratory investigations and/or data analysis
• Continuously drives to improve processes for improved performance
Requirements:
• BS/BA in engineering or scientific discipline
• 0-2 years of experience for Associate Specialist, 2+ years of experience for Specialist, and 5+ years of experience for Sr Specialist in a pharmaceutical/biologics cGMP environment