Job Description
**Job Summary:** Supports the Drug Product Manufacturing Sciences and Technology departments through monitoring process performance, data trending, and laboratory testing. **Job Description:** We are seeking a skilled professional to join our team as a **Drug Product Manufacturing Specialist**. As a key member of our team, you will be responsible for supporting the design and development of drug product processes, troubleshooting, and validation of drug product processes at manufacturing sites. **Key Responsibilities:** * Monitor process performance, data trending, and laboratory testing to ensure compliance with regulatory requirements * Support the implementation, expansion, and continuous improvement of Regeneron's Application for Data Aggregation and reporting system * Manage quality system events pertaining to data integrity and data management * Track trending process performance to establish/improve process capability * Author policies, technical reports/protocols, and change controls in support of cGMP activities * Lead efforts associated with the drug product Continued Process Verification (CPV) and In Process Control (IPC) initiative * Collaborate with cross-functional teams to define and execute drug product process development and technology transfer activities * Maintain required training status on Regeneron specific work instructions and SOPs **Requirements:** * Bachelor's degree in engineering or scientific discipline * 0-2 years of experience for Associate Specialist, 2+ years for Specialist, and 5+ years for Sr Specialist in pharmaceutical/biologics cGMP environment * Strong negotiation skills to reach consensus * Strong communication skills, both oral and written * Technical knowledge in drug product manufacturing, product development, and validation **Regeneron is an Equal Opportunity Employer:** We are committed to creating an inclusive and diverse culture that provides comprehensive benefits to our employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic.