We are seeking a highly motivated Associate Director 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 an Associate Director, a typical day may include the following: Reviewing sample analysis of pharmacok... more details
We are seeking a highly motivated Associate Director 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 an Associate Director, 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
Managing external/CRO collaborations
Working with internal cross-functional teams to ensure the successful integration of new technologies into our workflows and processes
Driving strategic planning and execution of development projects and ensuring alignment with overall department/collaborator objectives
Providing leadership and guidance to a team of scientists, fostering a culture of innovation, creativity, and collaboration
Contributing to regulatory submissions and responses to regulatory inquiries
Reviewing nonclinical study related document, including protocols, amendments, and reports
Reviewing SOPs, publications, and guidelines to ensure the process for bioanalysis is compliant with industry practice and/or regulatory expectations
Collaborating with Quality Assurance to ensure overall compliance with current regulations
This role might be for you if:
You have strong communication skills and can 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
Have the ability to think creatively and strategically with a strong problem-solving mentality
Have experience in leading teams and cross functional collaborations and enjoy mentoring others
In order to be considered for this role, you must have at least a Ph.D. and 10+ years or a BS/MS and 15+ years of relevant experience in bioanalysis or related field. 6-8+ years of pharmaceutical or biotech industry experience is required. We need someone to serve as a subject matter expert for external bioanalytical assay strategy and data interpretation. Hands-on experience with bioanalytical techniques such as ELISA, ECL, MSD, LC/MS, PCR-based methods is required. Must have strong knowledge and/or experience with pharmacokinetic (PK) and immunogenicity assays in support of nonclinical studies. Experience with outsourcing bioanalytical assays and oversight of CRO activities required. We need someone knowledgeable of bioanalytical regulatory guidances, including the GLPs, and industry standard practices for conducting nonclinical bioanalysis. Must have experience with writing/reviewing bioanalytical reports and contributing to regulatory submissions. Experience managing a team of scientists of varying different levels is required.
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.
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