Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary: Support the IOPS QC organization as the point person for GMP compliance. Report quality system metrics to the group and identify improvements that can be made in all quality system inputs. The ideal candidate will be a detail oriented who has spent time on the bench in a QC environment and has overseen a variety of GMP laboratory investigations.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Responsible for authoring and reviewing of the following types of documents, relating to area functions:
• failure investigations
• change control documents
• corrective/preventative action documents
• standard operating procedures
• validation protocols and summary reports

• Conduct cross functional laboratory investigations that may span the entire QC department and coordination of resources from multiple departments
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
• Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
• Strive for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
• Identify laboratory errors, trend and initiate appropriate CAPAs to eliminate recurrences.
• Represent QC on interdepartmental teams and in meetings.
• Perform job duties with little direction from management.
• Produce and maintain accurate records
• Assist in performing laboratory inspections for GMP compliance, suggest and implement corrective actions to keep the laboratory in inspection ready state
• Participate in and support regulatory audits as required
• Support other duties assigned by QC Management

Education and Experience:

• A third level qualification (BSc degree or higher) in in scientific discipline or related field with 2+ years ‘experience in pharmaceutical or related industry.
• Excellent communication skills, both verbal & written.
• Collaboration and teamwork. Maintains the highest standards of ethical behavior.
• Results and performance driven.
• Strong analytical ability and associated problem solving.
• Good time management and attention to detail.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.