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 Bioassays 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.
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 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. #J-18808-Ljbffr