QC Lab Instrumentation Analyst (Instrument Onboarding)

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Support the Quality Control (QC) department by facilitating and coordinating the process of instrument acquisition, enrollment, and qualification through project planning and execution.

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

• Facilitate all activities related to the onboarding of QC laboratory instruments (this includes assessment prior to purchasing, procurement, enrollment, and qualification).

• Identify and document system requirements to support the instrument qualification process (ex. system requirement specifications, system impact assessments).

• Develop and manage timelines for each equipment onboarding project.

• Manage the day-to-day detailed aspects of multiple projects simultaneously.

• Regularly communicate project progress and risks to all stakeholders and management.

• Coordinate and drive contingency and risk mitigation planning for projects.

• Acts as liaison with QC testing groups, IT, Lab Systems and QA Validation.

• Conduct instrument testing or feasibility studies (hardware and software) to determine if proposed equipment meet internal and regulatory requirements.

• Review / approve all documentation in support of qualifications.

Education and Experience:

• BS/BA in Life Sciences, Engineering, or related field preferred; will substitute relevant experience for education.

• Excellent interpersonal, communication, and problem-solving skills are essential.

• Demonstrated ability to successfully manage projects is required.

• Experience with analytical testing in a cGMP laboratory setting preferred.

• Strong working knowledge of MS Project preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.