Senior QC Specialist Role
This role involves performing assay transfers, validation, and investigation activities for quality control (QC). It also requires providing technical support, guidance, and supervision for release, stability, and in-process testing and assay development.
Key Responsibilities:
* Performing assay validation for QC
* Reviewing new test procedures and assays
* Evaluating and implementing new methodologies, techniques, and equipment as needed
* Generating compliance records, CAPAs, change controls, and deviation notifications as needed
* Evaluating assay performance through yearly method performance reports
* Facilitating assay transfers from R&D to business partners
* Organizing analytical assay transfer internally and externally
* Performing additional studies supporting regulatory filing
* Participating in technical troubleshooting and problem investigation
* Reviewing analytical development reports and other technical documents for technical correctness and regulatory compliance
* Supporting regulatory inspections and participating in cross-functional improvement initiatives/kaizens
Requirements:
* A Ph.D. in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries
* An M.Sc. with 7+ years of proven experience
* A B.Sc., which will be considered based on the candidate's years of experience and technical background, particularly within the pharmaceutical or biotechnology sectors
Regeneron Culture:
We have an inclusive and diverse culture that provides comprehensive benefits, including 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 welcomes applications from all qualified individuals 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.