Within this role you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.
As a QC Analyst within the Bioassay Lab, a typical day might include, but is not limited to, the following: Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs) Reviewing data from other analysts for accuracy and completeness Performing bioassays in compliance with cGMP practices Sub-culturing mammalian cell lines and performing cell counts Maintaining laboratory reagents and supplies Preparing reagent aliquots and media for use in cell-based assays Maintaining equipment in the laboratory Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT Initiating and completing CAPAs in accordance with site procedures Writing new and updating current SOPs as needed Presenting bioanalytical data reports clearly and concisely to management Identifying and implementing lab process improvements and lean initiative Performing any other duties relevant to the QC laboratory position as required This role might be for you if: You have current or prior experience working with Bioassay's in a regulated environment You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field or an equivalent combination of education and experience with 2+ years experience working in a regulated testing environment.
Previous experience working in a regulated Biotech environment is a distinct advantage.
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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. 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.