Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.
Summary: Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Essential Duties and Responsibilities; include, but are not limited to, the following:
- Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.
- Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).
- Performs or supports the sample analysis for microbial identification.
- Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
- Performs acceptance testing of commercially prepared microbiological culture media.
- Autoclaves microbiological media and laboratory waste as needed.
- 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.
- Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
- Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
- Participates in the transfer of methodology from other test facilities.
- Maintains laboratory reagents, media and supplies.
- 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 procedures.
- 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.
Additional responsibilities for Analysts II-IV include, but are not limited to:
- Increasing involvement in the training of employees.
- Increasing responsibilities for reviewing documents and data.
- Microbiology representation and participation in cross functional site meetings.
- Administration of programs such as gowning, training, ordering, calibration, etc.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Education and Experience:
- Requires BS/BA in Life Sciences or equivalent along with relative experience for levels beyond I (preferably in the pharmaceutical or biotechnology industries).
- Will substitute relevant work experience in lieu of degree requirement.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.