Temp QC Analyst - Biochemistry (Gels/Separations)

Within this role you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment. This is a 12 month contract position.

As a QC Analyst - Biochemistry (Gels/Separations)

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, conforms to company policies and standard operating procedures (SOPs)
• Reviewing data from other analysts for accuracy and completeness
• Performing review of test data on LIMS and Empower
• Performing gels/separations assays (CE-SDS, iCIEF, PICO MCE) in compliance with cGMP practices
• Performing data processing using Empower
• Maintaining laboratory reagents and supplies
• Preparing reagent aliquots and buffers for use in 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
• Performing any other duties relevant to the QC laboratory position as required

This role might be for you if:

• You have excellent verbal and written communication skills
• You have experience with electronic and systems such as Empower and LIMS
• You have experience with performing and reviewing separations assays
• You are an adaptable and flexible individual, willing to travel when needed

To be considered for this opportunity you should have a third level qualification (BSc degree or higher) in biology or related field or 2+ years relevant hands on work experience working in a laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.