Summary: Supports method lifecycle management within Quality Control (QC). This position utilizes and applies scientific knowledge and techniques to perform and review assay characterization, optimization, transfer, validation, and investigation. As a subject matter expert (SME), the role provides guidance, technical advice, and supervision for release, stability, in-process testing, and assay development.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Collaborate with Analytical Sciences (AS) to integrate methods into QC Commercial, evaluating and selecting suitable methods prior to process validation.

• Monitor and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed.

• Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management.

• Monitor method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites.

• Coordinate post-transfer investigations and multi-site trending, escalating issues to management when necessary.

• Drive process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers.

• Develop and draft new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports.

• Participate in training programs for QC personnel, ensuring all activities align with project timelines and deliverables.

Education and Experience:

• Assoc: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field, or equivalent combination of education and experience.

• Int: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 2+ years of experience or equivalent combination of education and experience.

• Sr: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 5+ years of experience or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00