Scientist (External CRO Management)

BioSpace; Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron is seeking a Scientist in Bioanalytical Outsourcing to oversee bioanalysis at external CROs, coordinating assay development, qualification, validation, and sample analysis across nonclinical and clinical programs.

This onsite role in Tarrytown, NY requires 10+ years in regulated bioanalysis, hands-on assay validation across LBA, LC/MS and PCR platforms, excellent documentation, and strong collaboration with project teams.

Qualifications

• BS/MS with 10+ years experience in an industry setting.
• Hands-on experience with regulated bioanalysis.
• Hands-on experience with assay validation/qualification across platforms: LBA, LC/MS, PCR-based methods.
• Excellent documentation skills with attention to detail and data quality.
• Strong communication of project goals and deliverables.
• Ability to multi-task and work under tight timelines.
• Preferred: experience managing external CROs and coordinating bioanalysis.
• Preferred: experience with gene therapies, CAR-T, mAbs, ADCs.

Responsibilities

• Provide scientific and operational oversight on all bioanalytical activities at CROs.
• Support CRO efforts in design, development, and implementation of analytical methods in regulated environment.
• Collaborate with internal SMEs to address issues during assay development and analysis.
• Interface with CROs to ensure on-time delivery and transparency of milestones and contracts.
• Provide CRO with materials, obtain documentation, reconcile concerns, arrange vendor visits.
• Facilitate GLP/GCLP compliance reviews at CROs.

Skills

Bioanalysis

Assay validation

GLP/GCLP

Documentation

Communication

Multi-tasking

CRO management

Drug candidates

Education

BS/MS degree

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.

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.
• Preferred: Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs 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 onsite.

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)

$93,900.00 - $153,300.00