Principal Scientist - Bioanalytical Outsourcing

Regeneron Pharmaceuticals, Inc.; USA; Vor Ort; USD 190.000 - 280.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking an Experienced Principal Scientist for Bioanalytical Outsourcing in Tarrytown, NY. Lead external CRO bioanalysis of PK, immunogenicity, and biomarkers, directing assay development/qualification/validation and downstream sample analysis and reporting.

You will communicate progress to stakeholders, ensure GLP/GCLP compliance, and collaborate with internal SMEs to resolve assay development and analysis issues. PhD with 10+ years in pharma is preferred.

Qualifikationen

• PhD with 10+ years of experience in the pharmaceutical industry.
• Experience managing external CROs in assay validation and bioanalysis.
• Hands-on with regulated bioanalysis including assay validation/qualification across multiple platforms (LBA, LC/MS, PCR).
• Strong communication skills and ability to work in a cross-functional environment.
• Ability to manage tight timelines and shifting priorities.

Aufgaben

• Provide scientific and operational oversight of bioanalytical activities at CROs, independently and with BOT representatives.
• Coordinate with CROs to obtain documentation, reconcile issues, and manage review meetings.
• Support design, development, and implementation of analytical methods in GLP/GCLP environments.
• Collaborate with internal and external SMEs to address assay development and sample analysis issues.
• Interface with CROs to ensure on-time milestone delivery and contract/PO management.
• Review pharmacokinetic, immunogenicity, and biomarker data to ensure data quality and integrity.

Kenntnisse

Scientific oversight

CRO management

Communication

Regulatory awareness

Ausbildung

PhD in Pharmaceutical Sciences or related

Tools

LBA

LC/MS

PCR-based methods

Jobbeschreibung

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: 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).

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.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we