As a Lead QC Analyst in the Biochemistry lab you will oversee a team of QC Biochemistry Analysts and ensure the day to day running of the laboratory is completed safely and efficiently to meet timelines.
You will perform duties to ensure cGMP compliance in the manufacturing facility. Your work will include planning, resource management, problem solving and performance management.
The Biochemistry group performs a variety of chemical or biological analyses on in-process, release and stability samples in support of the company's quality program.
Lead-Related Activities include, but are not limited to, the following:
- Providing on-the-floor guidance and support to your team of analysts
- Ensuring employees timesheets are completed on time
- Monitoring employees training to ensure that all requirements are met, including OJT
- Maintaining up to date training records for self and direct reports
- Performing minimally monthly performance feedback meetings with direct reports
- Escalating all performance issues to management and/or HR
A typical day might include, but is not limited to, the following:
- Gathering data and documenting test results
- Reviewing test results to ensure compliance with standards; reporting any quality anomalies
- Complying with all pertinent regulatory agency requirements
- Participating in required training activities
- Maintaining laboratory supplies
- Conducting testing on raw materials, in-process, product, stability, and/or research samples
- Writing and revising control test procedures and SOPs
- Completing test records and reviewing data
- Calibrating or verify calibration of instruments/devices prior to use
- Interacting with outside customers or functional peer groups
- May devise or develop new analytical methods and techniques
- May assist in validation of methods
- May be involved in establishing the transfer of methodology from R&D
This role might be for you if you have experience in one or more of the following areas:
- Binding Assays
- Cell based in-vitro bioassays
- Quantitative Real-Time PCR (qPCR)
- Imaging Capillary Isoelectric Focusing (ICEF)
- Capillary / Gel Electrophoresis, Western Blots
- Fluorescence microscopy, light phase microscopy
To be considered for this opportunity you should have a third level qualification (BSc degree or higher) in Biochemistry, Biology, Chemistry or related field. Preferably with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.
#LI-Onsite #REGNQC #JOBSIEST #IRELIM
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.