In this role you will perform a wide variety of analytical chemistry testing to support in-process and bulk drug substance manufacture in a cGMP regulatory environment.
Reporting to the QC Chemistry Lead, the person will be responsible for the following;
- Performing a wide variety of analytical chemistry testing to support in process and bulk drug substance release.
- Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
- Maintains laboratory reagents and supplies.
- Calibration of laboratory instruments.
- Participates in the transfer of methodology from other test facilities.
- Provides support and advice to manufacturing on QC related topics.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedure.
- Writes new and updates current SOPs as needed.
- Provides training to other analysts in the QC group.
- Presents analytical data reports clearly and concisely to management.
- Proactively identifies and implements lab process improvements, lean initiatives.
- Performs other duties relevant to the QC laboratory position as required.
- A third level qualification in a scientific/technical discipline.
- At least 1 year hands-on work experience in a regulated QC laboratory-testing environment within the biopharmaceutical/pharmaceutical industry.
- Excellent Communication skills, both verbal & written.
- Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise etc., is an advantage.
Preferred Laboratory Experience in one or more of the following areas
- UV-Vis spectrophotometry
- Wet chemistry testing techniques including pH, conductivity, appearance and osmolality
- Familiar with USP, JP and EP methodology
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.