Scientist (External CRO Management)

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Scientist to oversee all bioanalytical activities at external CROs for nonclinical and clinical programs. You will coordinate assay development, qualification, validation, and subsequent sample analysis and reporting for each drug program.

Collaborate with internal teams to ensure GLP/GCLP compliance and manage CRO relationships to deliver milestones on time while maintaining data integrity and regulatory standards.

Qualifications

• BS/MS with 10+ years industry experience.
• Hands-on regulated bioanalysis experience.
• Assay validation across LBA, LC/MS, PCR-based methods.
• Excellent documentation and data quality.
• Clear communication of goals and timelines.
• Ability to multi-task under tight timelines.
• Experience managing external CROs (preferred).
• Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs).

Responsibilities

• Provide scientific and operational oversight of bioanalytical activities at CROs.
• Support design, development and validation of analytical methods across platforms.
• Ensure on-time delivery of milestones and adherence to GLP/GCLP.
• Coordinate with SMEs to resolve assay development and analysis issues.
• Review GLP/GCLP compliance status at CROs.

Skills

Regulated bioanalysis

Assay validation

Documentation

Communication

Multi-tasking

Education

BS/MS with 10+ years in industry

Tools

LBA

LC-MS

PCR-based methods

Job description

Build our future together: A Scientist within the Bioanalytical Outsourcing will be responsible for overseeing all bioanalysis (nonclinical and clinical) at external CROs. They will be responsible for coordination of assay development/qualification/validation efforts on various analytical platforms as well as the subsequent sample analysis and reporting efforts for each drug program. They will be responsible for communicating progress on these deliverables to the appropriate nonclinical and clinical colleagues and project teams. The successful candidate will have demonstrated technical proficiency, solid understanding of the GLPs, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where: Location: Tarrytown, NY United State – Onsite

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 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. Provide CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate. Facilitate with the review of GLP and GCLP compliance status at CROs.

This role requires:

• A BS/MS with 10+ years experience in an industry setting.
• Hands-on experience with regulated bioanalysis.
• Hands-on experience with assay validation/qualification relevant under multiple platforms: LBA, LC/MS, PCR-based methods.
• Excellent documentation skills with attention to detail and overall data quality.
• Ability to clearly and concisely communicate project goals, deliverables internally and externally.
• Ability to multi-task and work under tight timelines.

Preferred:

• Previous experience managing external CROs, coordinating bioanalysis, assay validation etc.
• Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs 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, 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/.

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.

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 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) $93,900.00 - $153,300.00

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.

Regeneron is fully committed to creating a more inclusive environment and fosters a culture where people from all backgrounds can shape ideas and get rewarded for their talent directly.