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Senior Principal Scientist- Nonclinical Bioanalysis

Job Description

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We are seeking a highly motivated Senior Principal Scientist to join to our Nonclinical Bioanalysis (NBA) team. You will function as a Principal Investigator responsible for nonclinical bioanalysis of PK, Immunogenicity, and biomarkers. We hope you are excited by this opportunity to serve as a liaison between NBA and other nonclinical study teams to play a meaningful role in preclinical development.

As a Senior Principal Scientist, a typical day may include the following:

  • Reviewing sample analysis of pharmacokinetic, immunogenicity and biomarkers from nonclinical studies, as well as bioanalytical data to ensure the quality and integrity of data

  • Preparing and reviewing sample analysis documentation and nonclinical bioanalytical reports

  • Contributing to regulatory submissions and responses to regulatory inquiries

  • Reviewing nonclinical study related document, including protocols and amendments

  • Reviewing SOPs, publications, and guidelines to ensure the process for bioanalysis is compliant with industry practice and/or regulatory expectations

  • Serving as a subject matter expert for external bioanalytical assay strategy and data interpretation; supporting CRO monitoring and outsourced activities

  • Communicating with Quality Assurance to arrange critical phase audits, data, and report audits, as well as preparing audit responses

This role might be for you if:

  • You have strong managerial skills and enjoy mentoring others

  • You have strong communication skills and efficiently work in a cross-functional environment

  • You enjoy participating in, preparing, and presenting scientific data at internal and external project team meetings.

  • You have excellent multi-tasking skills and the ability to be flexible with changing priorities.

In order to be considered for this role, you must have at least a Ph.D. and 6-8+ years, an MS and 10-12+ years, or a BS and 12-14+ years of relevant experience in the pharmaceutical or biotech industry. Experience with bioanalytical techniques such as ELISA, ECL, MSD, LC/MS, PCR-based methods is required. Must have strong knowledge and/or experience with pharmacokinetics (PK) assays and immunogenicity assays in support of nonclinical studies (toxicology, pharmacokinetic).Experience with outsourcing bioanalytical assays and oversight of CRO activities required. We need someone familiar with bioanalytical regulatory guidance, including the GLPs, and industry standard practices for conducting nonclinical bioanalysis. Must have experience with writing/reviewing bioanalytical reports and contributing to regulatory submissions.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$141,800.00 - $231,400.00