Regeneron Pharmaceuticals, Inc

Scientist (External CRO Management)

Regeneron Pharmaceuticals, Inc • $93K — $153K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • BS/MS with 10+ years of industry experience
  • Hands-on experience in regulated bioanalysis
  • Proficient in assay validation/qualification across multiple platforms (LBA, LC/MS, PCR)
  • Strong documentation skills with a focus on data quality
  • Effective communicator of project goals and deliverables
  • Ability to manage multiple tasks under tight deadlines
  • Preferred: Experience managing external CROs and coordinating bioanalysis

Responsibilities

  • Oversee all bioanalytical activities at external CROs
  • Support CROs in designing and implementing analytical methods in a regulated environment
  • Collaborate with internal and external SMEs to resolve assay development issues
  • Ensure timely delivery of milestones by interfacing with CROs
  • Manage documentation and critical materials with CROs
  • Review GLP and GCLP compliance status at CROs
  • Facilitate standing review meetings and vendor visits as needed

Benefits

  • Onsite work location in Tarrytown, NY
  • Opportunity to work with cutting-edge drug candidates
  • Engagement in a team-oriented environment
  • Collaboration with industry experts and CROs
  • Involvement in both nonclinical and clinical bioanalytical processes
Full Job 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.

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).


Salary Range (annually)
$93,900.00 - $153,300.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

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Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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