Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.
As a Senior QC Scientist a typical day might include, but is not limited to, the following:
1. Executing investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support.
2. Evaluating/interpreting data, author and review technical documents for investigational testing.
3. Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices.
4. Participating in routine maintenance and troubleshooting of laboratory instrumentation.
5. Liaising with contract laboratories as required to support investigational analysis.
6. Tabulating results and writing summary reports of assay development and validation studies.
7. Presenting findings at group and interdepartmental meetings.
8. Producing and maintaining accurate records.
9. Generating and/or supports completion of compliance records, CAPAs, change controls and deviation notifications as needed.
10. Participating in technical troubleshooting and investigation.
11. Supervising junior level group members, acting as a mentor within the laboratory, including distributing workload, monitoring progress and reviewing/approving assigned work.
12. Supporting and participating in regulatory inspections.
13. Participating in cross-functional improvement initiatives/kaizens.
14. Participating in developing, maintaining and presenting operational metrics.
This role might be for you if you:
1. 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.
2. You are able to work in a team environment but can also take ownership of large technical reports and projects.
3. You can develop and drive scientific and/or business-related improvement ideas.
4. You have working knowledge of Microsoft Suite (Word, Excel, PowerPoint, etc.).
5. You understand working with statistical software such as JMP.
6. You enjoy developing novel assays independently.
7. You have development experience in identification-based analyses (e.g. FT-IR, SEM, ICP-MS, SEM, GC) in a GMP environment.
8. You have excellent fine motor skills.
To be considered for this opportunity you should hold a PhD in Biochemistry, Chemistry, Biology or related field and 2+ years of experience, preferably in the pharmaceutical or biotechnology industries. Alternatively, an MSc with 7+ 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.
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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