Job Summary:
This is a wide-ranging role that involves performing various bioanalytical processes to support the production of bulk drug substances in a controlled environment that meets regulatory requirements.
The ideal candidate will have experience working with Bioassays, be able to work independently or as part of a team, possess strong problem-solving skills, and have excellent attention to detail and written/oral communication skills.
Key Responsibilities:
* Ensure all work is conducted in compliance with GMP standards and company policies
* Review data from other analysts for accuracy and completeness
* Perform bioassays in line with cGMP practices
* Sub-culture mammalian cell lines and conduct cell counts
* Maintain laboratory reagents and supplies
* Prepare reagent aliquots and media for use in cell-based assays
* Maintain equipment in the laboratory
* Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT
* Initiate and complete CAPAs in accordance with site procedures
* Write new and update current SOPs as needed
* Presentation of bioanalytical data reports to management
* Identify and implement lab process improvements and lean initiative
* Perform any other duties relevant to the QC laboratory position as necessary
Requirements:
* BS/BA in Life Sciences or related field or equivalent combination of education and experience
* 2+ years experience working in a regulated testing environment
* Previous experience working in Biotech environment is an advantage
Regeneron Values:
* Inclusive and diverse culture
* Comprehensive benefits package
* Equal opportunity employer