-
Job Description
Supports the Drug Product Manufacturing Sciences and Technology departments through monitoring process performance, data trending, data analysis, and laboratory testing.
Provides support for the design and development of drug product processes and will be part of a team responsible for industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic.
A typical day might include:
- Performing verified data entry tasks into electronic systems in a timely and efficient manner
- Tracking cycle time and metrics for data entry process
- Supporting the implementation, expansion, and continuous improvement of Regeneron's Application for Data Aggregation and reporting system
- Managing quality system events pertaining to data integrity and data management
- Tracking trending process performance to establish/improve process capability
- Authoring policies, technical reports/protocols, change controls, etc.
- Leading efforts associated with the drug product Continued Process Verification (CPV)
- Maintaining required training status on Regeneron specific work instructions and SOPs
- Collaborating with cross-functional teams to define and execute drug product process development and technology transfer activities
- Collaborating with peers to procure, implement, and evaluate new technologies for potential future use in the drug product process
- Supporting process investigations and assists with product impact assessment for change controls and internal/external investigations
- Continuously driving to improve processes for improved performance
This role requires:
- The ability to work independently or as part of a team
- Strong negotiation skills to reach consensus
- Strong communication skills, both oral and written
- Technical knowledge in drug product manufacturing, product development, and validation
To be considered for this position, you must have a BS/BA in engineering or scientific discipline.
Experience requirements:
- Associate Specialist: 0-2 years experience
- Specialist: 2+ years experience in pharmaceutical/biologics c GMP environment
- Sr Specialist: 5+ years experience in pharmaceutical/biologics c GMP environment