Within this role, you will be part of the QC Technical Resources Material Identification Team and responsible for identifying unknown material observed at IOPS. As a QC Technical Resources Specialist, your typical day might include:
* Driving investigation testing (FT-IR, SEM, ICP-MS, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support.
* Evaluating/interpreting data, authoring and reviewing technical documents for investigational testing.
* Establishing, developing, and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices.
* Participating in routine maintenance and troubleshooting of laboratory instrumentation.
* Liasing with contract laboratories as required to support investigational analysis.
* Tabulating results and writing summary reports of assay development and validation studies.
* Presenting findings at group and interdepartmental meetings.
* Producing and maintaining accurate records.
* Generating and/or supporting completion of compliance records, CAPAs, change controls, and deviation notifications as needed.
* Participating in technical troubleshooting and investigation.
* Supervising junior level group members, acting as a mentor within the laboratory, including distributing workload, monitoring progress, and reviewing/approving assigned work.
* Supporting and participating in regulatory inspections.
* Participating in cross-functional improvement initiatives/kaizens.
* Developing, maintaining, and presenting operational metrics.
You Might Be the Right Fit If:
* You enjoy working in a fast-paced environment and have the innate ability to balance multiple projects, prioritize them, and complete 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.
* You have development experience in identification-based analyses (e.g., FT-IR, SEM, ICP-MS, GC) in a GMP environment.
Requirements:
* You should hold a BS/BA in a life sciences field.
* You should have 2+ years of relevant experience in a cGMP environment or an equivalent combination of education and experience.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, 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.