Description

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.

In this role, a typical day might include the following:

Provide scientific and operational oversight on all aspects of bioanalytical activities conducted at Contract Research Organizations (CROs), independently and in collaboration with representative 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 job might be for you if you:

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

To be considered for this role, you must have:

BS/MS with 10+yrs 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$93,900.00 - $153,300.00

Scientist (External CRO Management)

Description

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