QC Specialist in Newtown

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.

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

To be considered for this role, you must meet the following:

• 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

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.

Salary Range (annually) $71,800.00 - $116,800.00

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), 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 in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.