As a QC Staff Scientist in Biochemistry, you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance, and supervision for release, stability, and in-process testing and assay development/validation and/or transfer.
In this role, a typical day might include, but is not limited to, the following:
1. Participating in assay development/validation for QC
2. Reviewing and approving new test procedures and assays
3. Evaluating new methodologies, techniques, and equipment when new procedures are warranted
4. Participating in the transfer of methodology from R&D
5. Generating and/or supporting the completion of compliance records, CAPAs, change controls, and deviation notifications as needed
6. Evaluating assay performance through yearly method performance reports
7. Facilitating assay transfer from R&D and to business partners
8. Providing technical input into additional studies supporting regulatory filing e.g., Bridging/comparability studies
9. Participating in technical troubleshooting and problem investigation
10. Reviewing analytical development reports, assay and process validation reports, and other technical documents for technical correctness and regulatory compliance
11. Participating in training programs for Analysts
12. Supporting and participating in regulatory inspections
13. Participating in cross-functional improvement initiatives/kaizens
14. Participating in data review for technical correctness and regulatory compliance
15. Bringing new technologies and techniques into QC
16. Assisting in writing technical sections of regulatory submissions
This role might be for you if you:
1. Enjoy working in a fast-paced environment and have the innate ability to balance multiple projects, prioritize them, and execute them independently while excelling at keeping all impacted parties well advised.
2. Can work in a team environment but also take ownership of large technical reports and projects.
3. Can develop and drive scientific and/or business-related improvement ideas.
4. Have working knowledge of Microsoft Suite (Word, Excel, PowerPoint, etc.).
5. Understand working with statistical software such as JMP.
6. Enjoy developing novel assays independently.
To be considered for this opportunity, you should hold a PhD in Biochemistry, Chemistry, Biology, or a related field and 5+ years of experience, preferably in the pharmaceutical or biotechnology industries, or an MSc with 9+ years of experience, preferably in the pharmaceutical or biotechnology industries.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan, or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.
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