Job Description
As a QC Staff Scientist in Biochemistry, you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance, and supervision for release, stability, and in-process testing and assay development/validation and/or transfer.In this role a typical day might include, but is not limited to, the following:Participating in assay development/validation for QCReviewing and approving new test procedures and assaysEvaluating new methodologies, techniques and equipment when new procedures are warrantedParticipating in transfer of methodology from R&DGenerating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as neededEvaluating assay performance through yearly method performance reportsFacilitating assay transfer from R&D and to business partnersProviding technical input into additional studies supporting regulatory filing e.g., Bridging/comparability studiesParticipating in technical troubleshooting and problem investigationReviewing analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory complianceParticipating in training programs for AnalystsSupporting and participating in regulatory inspectionsParticipating in cross-functional improvement initiatives/kaizensParticipating in data review for technical correctness and regulatory complianceBringing new technologies and techniques into QCAssisting in writing technical sections of regulatory submissionsTo be considered for this opportunity you should hold a PhD in Biochemistry, Chemistry, Biology or related field and 5+ years of experience, preferably in the pharmaceutical or biotechnology industries, or MSc with 9+ years of experience, preferably in the pharmaceutical or biotechnology industries.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.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. #J-18808-Ljbffr