The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes
Job Summary
The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes.
Candidates will implement continued process verification, utilize data trending for risk identification, and lead technical transfer activities for OSD formulations.
The position requires managing compliance records, leading change controls, and collaborating with cross-functional teams on validation and investigations.
Matching Summary
The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes.
Skills & Requirements
Must-have
BS degree in Chemistry or Engineering
3+ years in Manufacturing Science
Knowledge of FDA and GMP regulations
Experience with SAP systems
Project management skills
Problem solving and continuous improvement tools
Nice-to-have
Fluent in English and Spanish
Experience with eBR and Serialization
Ability to articulate business vision
Teamwork and inspiring others
Participation in Performance Centric Teams
Key Requirements
Minimum 3 years experience in Manufacturing Science
BS degree in Chemistry, Engineering, or related area
In-depth understanding of production forecasts and SAP systems
Experience implementing FDA and/or GMP regulations