Principal Scientist - Bioanalytical Outsourcing

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

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Principal Scientist to lead external bioanalytical outsourcing for PK, immunogenicity, and biomarkers across nonclinical and clinical programs.

You will oversee assay development, qualification, validation, sample analysis, and reporting at CROs, ensuring GLP/GCLP compliance and data integrity. You will provide scientific and operational oversight, manage CRO interactions, review data, and coordinate timelines, milestones, and

Qualifications

• 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.
• PhD with 10+ years of experience in the Pharmaceutical Industry.
• Preferred: Experience with novel drug candidates (gene therapies, CAR-T, ADCs, AOCs, etc).

Responsibilities

• Oversee all bioanalysis at CROs for PK, immunogenicity and biomarkers in nonclinical and clinical programs.
• Provide scientific and operational oversight on CRO bioanalytical activities.
• Coordinate CRO interactions, vendor documentation, and standing review meetings.
• Support assay development/qualification/validation across platforms in GLP/GCLP environments and ensure regulatory alignment.
• Collaborate with SMEs to address issues during assay development and data analysis.
• Review pharmacokinetic, immunogenicity, and biomarker data from studies to ensure data quality.

Skills

CRO management

Bioanalytical oversight

Cross-functional collaboration

Regulatory compliance

LBA methods

LC-MS

PCR-based assays

Strategic thinking

Problem solving

Communication skills

Education

PhD in Pharmaceutical Sciences

Tools

LBA platforms

LC/MS platforms

PCR-based methods

Job description

Experienced – Principal Scientist, Bioanalytical Outsourcing Bioanalytical Outsourcing Team

Build our future together:

Location: Tarrytown, NY United States

Discover your role:

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.

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).

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
• 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.

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.

Salary Range (annually) $128,600.00 - $210,000.00

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.