Regeneron Pharmaceuticals, Inc

Sr Clinical Supply Operations Specialist

Regeneron Pharmaceuticals, Inc • $83K — $136K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BS/BA degree in a related field
  • 3+ years of experience in Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, or Manufacturing
  • Fundamental knowledge of clinical drug development and trial methodology
  • Understanding of ICH/GCP and regulatory guidelines
  • Proficient in MS Word and Excel

Responsibilities

  • Support IP distribution and ancillary supplies processes
  • Manage inventory planning, including accountability and reconciliation
  • Oversee IP shipments and temperature excursion management
  • Document management for eTMF and QA/QP release
  • Plan and manage ancillary supply logistics and vendor support
  • Conduct financial forecasting and budgeting for clinical supplies
  • Lead short-term projects and represent CDSL in cross-functional interactions

Benefits

  • Opportunity to contribute to a science-driven organization
  • Engagement in complex problem-solving
  • Involvement in cross-functional projects
  • Potential for professional growth in a fast-paced environment
  • Travel opportunities up to 25%
Full Job Description
The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas supporting highly complex studies as well as long-term departmental and cross-functional projects and on-going continuous improvement initiatives. May lead short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Warren, NJ or Armonk, NY

Travel percentage: Up to 25%

Discover your role
Solve complex problems, and initiate completion of the following items within broadly defined practices and policies including selecting methods, techniques, and evaluation criteria for obtaining results related to:
• IP Supply & Inventory Planning

o Accountability, Reconciliation, Returns & Destruction (ARRD)

o Internal System Management including lot creation, batch status, and inventory maintenance

o Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments

o System and Non-system generated Shipments

o Depot transfers

o Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)

o Expected Document List (EDL) creation

o eTMF Document Management per regulatory requirements

o QA/QP Release Management

o Pack-and-label kit and sequence reconciliation o Inspection Readiness activities

o IRT management activities including IRT Alert management and UAT activities

o Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management

o Procurement support (Includes Work Order Management)

o Vendor RFI support o Supply Planning & Inventory Management

o Ancillary Supply Plan creation

o Shipping & Logistics (Includes International Logistics requirements for Ancillaries)

o Shipping & logistics activities

o Temperature Excursions

o Lot management o eTMF activities

o ARRD activities
• Comparator Planning & Management

o Market Intelligence Reports o Quote/PO/Requisition Process Support

o IMN Creation

o Document Storage

o Temperature Excursions
• Financial Forecasting, Budgeting & Planning

o Forecast Submissions

o Order Ticket Entry

o Demand Updates

Work is performed under general direction and reviewed upon completion for adequacy in meeting objectives. Candidate is expected to participate in determining objectives of assignment and be able to plan schedules and arrange own activities in accomplishing objectives. Candidate will represent CDSL as a prime contact on contracts or projects. He/She will interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

JOB REQUIREMENTS:Fundamental knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners.

Fundamental knowledge of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives
• Proficient in MS Word & Excel
• Efficient Problem Solving
• Excellent Time Management
• Thrives in Ambiguity
• Action Oriented
• Adaptability
• Collaborates Effectively
• Well Organized
• Communicates Effectively
• Detail Oriented

MINIMAL EDUCATION REQUIRMENTS

BS/BA degree in a related field. Minimum of 3+ years of experience in the following fields:
• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Or equivalent research/commercial biopharma experience

Salary Range (annually)
$83,800.00 - $136,800.00

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

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
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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