As a QC Analyst (Separations) you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Ensure that all work carried out is in compliance with current GMP, the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Peer review data from other analysts for accuracy and completeness.
- Perform gels/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices.
- Perform data processing using Empower.
- Maintain laboratory reagents and supplies.
- Preparation of reagent aliquots and buffers for use in assays.
- Maintenance of equipment in the laboratory.
- Conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiate and complete CAPAs in accordance with site procedures.
- Write new and updates current SOPs as needed.
- Present bioanalytical data reports clearly and concisely to management.
- Proactively identify and implement lab process improvements, lean initiatives.
- Perform any other duties relevant to the QC laboratory position as required.
To be considered for this opportunity you should have a third level qualification (BSc degree or higher) in biology or related relevant hands-on work experience working in a laboratory to cGMP regulatory guidelines within the biopharmaceutical industry
Preferred Laboratory Experience in one or more of the following areas
- Gel based Assays
- HPLC/Separation knowledge
#IRELIM #JOBSIEST #LI-Onsite #REGNQC #REGNIEEC
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.