A typical day might include:
Supervising QC Chemistry activities such as: complex laboratory investigations, instrument trouble shooting, creation/revision of laboratory procedures and implementation of new software systems/instrumentation and equipment.
Ensuring that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
Performing procedural gap analysis, identifies continuous improvement and lessons learned opportunities and implements solutions.
Providing advice and mentorship to cross-functional teams to enable successful laboratory operations.
Collaborating with internal and external teams to harmonize operations and ensure consistency the laboratories.
Serving as Subject Matter Expert (SME) for laboratory operations for QC Chemistry.
Implementing and/or coordinates the completion of laboratory related protocols.
Ensuring timely completion of non-testing activities impacting lab operations (ex. Logbook replacement, data package assembly).
Developing excellent communication and working relationships with QC personnel responsible for deliverables as well as cross-functional team members.
Facilitating inspection readiness activities in QC and participates in audits and inspections.
May perform testing and data review functions.
Senior level may perform review and approval of laboratory investigations.
This role might be for you if you:
Have excellent written and oral communication skills.
Are able to work independently or part of a cross-functional team.
Have experience in a GMP setting
Have an understanding of performing investigations for laboratory deviations and non-conformances.
Have knowledge in analytical testing procedures for HPLC and Chemistry testing.
To be considered for this role you must have a BS/BA in a scientific field and
Specialist : 2+ years of related experience or equivalent combination of education and experience.
Sr Specialist: 5+ years of related experience or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually) $66,400.00 - $126,800.00
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