QC Specialist
Regeneron, Cambridge, MA, United States
Our QC Specialist supports the Phase 1 GMP testing laboratory for release and stability for multiple stages of our cell and gene therapy products. This includes performing analytical methods, reviewing and trending data, and supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. The role interfaces with Analytical Development, Method Validation, Quality Assurance, IT, Facilities, and other cross‑functional teams as required. The candidate must have a cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology.
Typical Day May Include
Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA)
Review and evaluate raw data at peer‑review level
Author SOPs/FORMs and technical reports with guidance
Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols, and investigation closure with guidance
Author, review and execute equipment validations with guidance
Support operational systems (equipment/instrument maintenance and calibration, equipment alarm monitoring, sample handling and 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
Required Qualifications
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 communication skills and a "do‑what‑it‑takes" attitude
Strong capacity to learn and receptiveness to change
Self‑directed individual capable of working with limited direction in a fast‑paced, goal‑oriented environment
Benefits
We offer a comprehensive benefits program that includes health and wellness benefits (medical, dental, vision, life, and disability insurance), fitness centers, a 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave for eligible employees. Benefits may vary by location.
Salary
$71,800.00 – $116,800.00 per annum.
Equal Opportunity Employer
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
Background Checks
Background checks are conducted in accordance with the law of the country where the position is based and may include verification of identity, right to work, educational qualifications, etc.
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Typical Day May Include
Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA)
Review and evaluate raw data at peer‑review level
Author SOPs/FORMs and technical reports with guidance
Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols, and investigation closure with guidance
Author, review and execute equipment validations with guidance
Support operational systems (equipment/instrument maintenance and calibration, equipment alarm monitoring, sample handling and 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
Required Qualifications
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 communication skills and a "do‑what‑it‑takes" attitude
Strong capacity to learn and receptiveness to change
Self‑directed individual capable of working with limited direction in a fast‑paced, goal‑oriented environment
Benefits
We offer a comprehensive benefits program that includes health and wellness benefits (medical, dental, vision, life, and disability insurance), fitness centers, a 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave for eligible employees. Benefits may vary by location.
Salary
$71,800.00 – $116,800.00 per annum.
Equal Opportunity Employer
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
Background Checks
Background checks are conducted in accordance with the law of the country where the position is based and may include verification of identity, right to work, educational qualifications, etc.
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