Bioanalytical QC Analyst
Regeneron Pharmaceuticals is seeking a highly skilled Bioanalytical QC Analyst to join our team in a cGMP regulatory environment.
Key Responsibilities:
* Ensure all work is compliant with current GMP, regulatory standards, company policies, and standard operating procedures (SOPs).
* Review data from other analysts for accuracy and completeness.
* Perform bioassays in line with cGMP practices.
* Sub-culture mammalian cell lines and perform 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.
* Present bioanalytical data reports clearly and concisely to management.
* Identify and implement lab process improvements and lean initiatives.
* Perform any other duties relevant to the QC laboratory position as needed.
Requirements:
* BS/BA in Life Sciences or related field or an equivalent combination of education and experience.
* 2+ years of experience working in a regulated testing environment.
* Experience working with molecular biology and cell biology techniques such as ELISA, Bioassays, and mammalian cell culture.
Preferred Qualifications:
* Previous experience working in a Biotech environment.
This role involves performing a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment. If you have a strong background in bioassays, troubleshooting, and problem-solving, this could be the opportunity for you.