Principal Scientist - Bioanalytical Outsourcing

Regeneron Pharmaceuticals Inc.; Village of Tarrytown (NY); On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) plan

Health benefits

Wellness programs

Fitness centers

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals Inc. in New York seeks a highly skilled Principal Scientist to lead and oversee the Bioanalytical Outsourcing Team, ensuring robust PK, immunogenicity, and biomarker analyses at external CROs across multiple platforms, under GLP/GCLP frameworks.

You will direct assay development/qualification/validation, coordinate sample analysis and reporting for drug programs, and communicate progress to stakeholders with scientific rigor and strategic flair.

Qualifications

• Previous experience in managing external CROs in assay validation and bioanalysis.
• Strong communication skills and the ability to work in a cross-functional environment.
• Ability to work under tight timelines and be flexible with changing priorities.
• 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).

Responsibilities

• Provide scientific and operational oversight on all bioanalytical activities conducted at Contract Research Organizations (CROs).
• Provide CRO with critical material and documentation; reconcile scientific or operational concerns; manage review meetings and vendor visits.
• Provide scientific support to CRO efforts in design, development, and implementation of analytical methods in a regulated environment.
• Work 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 maintain contract/quotes/purchase orders.
• Review sample analysis of pharmacokinetic, immunogenicity, and biomarkers to ensure data quality and integrity.

Skills

CRO management

Cross-functional communication

Regulated bioanalysis

Multi-tasking

Problem solving

Education

PhD in Pharmaceutical/related field

Tools

LBA platform

LC-MS

PCR-based methods

Job description

Experienced – Principal Scientist, Bioanalytical Outsourcing

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:

Location: Tarrytown, NY United States

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).

Does this sound like you?

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.

• 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
• family support benefits

Salary Range (annually)

$128,600.00 - $210,000.00

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.

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.