QC Specialist

Regeneron Pharmaceuticals • Cambridge, MA

1d • Onsite

About The Position

Our QC Specialist supports Phase 1 GMP testing laboratory for release and stability for multiple stages of our cell and gene therapy products. This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. They interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. They have a cGMP operational and technical background in cell biology, biochemistry and/or molecular biology. As a QC Specialist, a typical day may include: Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA) Review and evaluate raw data (peer review level) Author SOPs/FORMs and technical reports with guidance Initiate laboratory deviations and support investigations (IA, OOS, AR) performing assessment, authoring protocols/ reports and investigation closure with guidance Author, review and execute equipment validations with guidance Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training) Execute phase-appropriate test method validation protocols, as needed Participate in providing the necessary information to support regulatory filings and inspections Support CAPA/Continuous Improvement initiatives Must be flexible to support shift work, as needed

Requirements

• BS in Biotechnology discipline
• 2+ years experience in cGMP/GxP environment
• Hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods, such as ELISA
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
• Strong capacity to learn and receptive to change
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

Responsibilities

• Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA)
• Review and evaluate raw data (peer review level)
• Author SOPs/FORMs and technical reports with guidance
• Initiate laboratory deviations and support investigations (IA, OOS, AR) performing assessment, authoring protocols/ reports and investigation closure with guidance
• Author, review and execute equipment validations with guidance
• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
• Execute phase-appropriate test method validation protocols, as needed
• Participate in providing the necessary information to support regulatory filings and inspections
• Support CAPA/Continuous Improvement initiatives
• Must be flexible to support shift work, as needed

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees