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: Perform assay transfer, validation and investigation activities for QC. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Performs assay validation for QC.
- Reviews new test procedures and assays.
- Evaluates and bring in new methodologies, techniques, and equipment as needed
- Generates and/or supports completion of compliance records, CAPAs, change controls and deviation notifications as needed
- Evaluates assay performance through yearly method performance reports
- Facilitate assay transfer from R&D and to business partners
- Organize analytical assay transfer internally and externally
- Performs additional studies supporting regulatory filing eg. Bridging/comparability studies
- Participates in technical troubleshooting and problem investigation
- Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
- Participates in training programs for analysts
- Support and participate in regulatory inspections
- Participates in cross-functional improvement initiatives/kaizens
Education and Experience:
- Requires PhD in Biochemistry, Chemistry, Biology or related field and 2+ years of experience, preferably in the pharmaceutical or biotechnology industries. MSc with 7+ years of experience, preferably in the pharmaceutical or biotechnology industries.
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 excellent benefits including health and wellness programs, fitness centres 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.