Principal Scientist - Bioanalytical Outsourcing

Regeneron; Village of Tarrytown (NY); On-site; USD 180,000 - 230,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a highly motivated Principal Scientist to lead bioanalytical outsourcing efforts, overseeing PK, immunogenicity, and biomarker analyses at CROs under GLP/GCLP guidelines.

The role involves supervising assay development/qualification/validation, sample analysis, and reporting for multiple drug programs. The candidate will collaborate with internal SMEs and external CROs to ensure on-time delivery, regulatory compliance, and rigorous data quality across

Qualifications

• Experience in managing external CROs in assay validation and bioanalysis.
• Hands-on experience with regulated bioanalysis including assay validation/qualification under multiple platforms: LBA, LC/MS, PCR-based methods.
• Ph.D. with 10+ years of experience in the Pharmaceutical Industry.

Responsibilities

• Provide scientific and operational oversight on all bioanalytical activities conducted at CROs, independently and with BOT representatives.
• Provide CRO with critical material and documentation, coordinate vendor visits and reconciliation of concerns.
• Provide scientific support to CRO efforts in design, development, and implementation of analytical methods in a regulated environment.
• Collaborate with internal and external SMEs to address issues during assay development and sample analysis.
• Interface with CROs to ensure on-time delivery of milestones and manage budgets/contracts.

Skills

CRO management

Bioanalytical oversight

GLP/GCLP knowledge

LBA

LC/MS

PCR-based methods

Regulatory guidance

Communication skills

Education

Ph.D. in Pharmaceutical Sciences (or related)

Job description

Principal Scientist - Bioanalytical Outsourcing

Experienced – Principal Scientist, Bioanalytical Outsourcing

Bioanalytical Outsourcing Team

Build our future together:

We are seeking a highly motivated Principal Scientist to join to our Bioanalytical Outsourcing Team (BOT). As Principal Scientist in the BOT, you will be responsible for overseeing all bioanalysis of PK, Immunogenicity, and biomarkers (nonclinical and clinical) at external CROs, including management of assay development/qualification/validation efforts on various analytical platforms as well as the subsequent sample analysis and reporting efforts for each drug program. You will be responsible for communicating status and progress on these deliverables to the appropriate stakeholders. The successful candidate will have demonstrated technical proficiency, solid understanding of the GLPs and GCLPs, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment.

When & where:

Discover your role:

• Provide scientific and operational oversight on all aspects of bioanalytical activities conducted at Contract Research Organizations (CROs), independently and in collaboration with representatives of the Bioanalytical Outsourcing Team.
• Provide CRO with critical material, obtain needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate.
• Provide scientific support to CRO efforts in design, development, and implementation of a variety of analytical methods in a regulated (GLP, GCLP) environment and ensure that these activities are in line with current regulatory guidelines.
• Work with internal and external SMEs (Subject Matter Experts) to address any/all issues that may occur during assay development and/or sample analysis.
• Interface with CROs to ensure on time delivery of required milestones and proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders etc.
• Reviewing sample analysis of pharmacokinetic, immunogenicity, and biomarkers from nonclinical studies, as well as bioanalytical data to ensure the quality and integrity of data.

This role requires:

• Previous experience in managing external CROs in assay validation and bioanalysis.
• Strong communication skills and the ability to efficiently work in a cross-functional environment.
• Ability to work under tight timelines and be flexible with changing priorities.
• Ability to think creatively and strategically with strong problem-solving and multi-tasking skills.
• Hands‑on experience with regulated bioanalysis including assay validation/qualification under multiple platforms: LBA, LC/MS, PCR‑based methods.
• A Ph.D. with 10+ years of experience in the Pharmaceutical Industry.
• Preferred: Experience with novel drug candidates (gene therapies, CAR‑T, ADCs, AOCs, etc).

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.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.

• Location: Tarrytown, United States of America
• Location: Tarrytown, United States of America
• Location: Tarrytown, United States of America

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one‑way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

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