As a Senior QC Scientist you will 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.
In this role a typical day might include, but is not limited to, the following:
* Performing assay validation for QC.
* Reviewing new test procedures and assays.
* Evaluating and bringing in new methodologies, techniques, and equipment as needed
* Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed
* Evaluating assay performance through yearly method performance reports
* Facilitating assay transfers from R&D and to business partners
* Organizing analytical assay transfer internally and externally
* Performing additional studies supporting regulatory filing eg. Bridging/comparability studies
* Participating in technical troubleshooting and problem investigation
* Reviewing analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
* Participating in training programs for analysts
* Supporting and participating in regulatory inspections
* Participating in cross-functional improvement initiatives/kaizens
This role might be for you if you:
* You enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised.
* You are able to work in a team environment but can also take ownership of large technical reports and projects.
* You can develop and drive scientific and/or business-related improvement ideas.
* You have working knowledge of Microsoft Suite (Word, Excel, Powerpoint,etc).
* You understand working with statistical software such as JMP.
* You enjoy developing novel assays independently.
To be considered for this opportunity you should hold a PhD in Biochemistry, Chemistry, Biology or related field and 0-2 years of experience, preferably in the pharmaceutical or biotechnology industries or MSc with 4+ years of experience, preferably in the pharmaceutical or biotechnology industries.
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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.