Sr Clinical Supply Operations Specialist

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 84,000 - 137,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Sr. Clinical Supply Operations Specialist to support IP distribution, ancillary supplies, and comparator procurement across multiple studies.

Based in Warren, NJ or Armonk, NY, you’ll lead IP shipments, inventory planning, and eTMF documentation, coordinating with CROs and internal partners to ensure on‑time, compliant delivery. We require a BS/BA and 3+ years in clinical supplies, QA/regulatory, or related biopharma fields; strong MS Word/Excel

Qualifications

• Fundamental knowledge of the clinical drug development process and trial methodology.
• Fundamental knowledge of ICH/GCP and regulatory guidelines.
• Proficient in MS Word & Excel; strong problem solving and time management.

Responsibilities

• IP Supply & Inventory Planning: ARRD, batch status, and inventory maintenance.
• IP Shipments: system/non-system shipments, depot transfers, temperature control.
• IP Supply Monitoring & eTMF: EDL creation, document management, QA/QP release.
• Ancillary Supply & Inventory: procurement support, vendor RFI, shipping requirements.
• Comparator Planning: market intelligence, quotes, requisitions, documentation.

Skills

MS Word

Excel

Proactive problem solving

Time management

Communication

Detail oriented

Collaborates effectively

Organized

Education

BS/BA degree in related field

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

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

• IP Supply & Inventory Planning
  • Accountability, Reconciliation, Returns & Destruction (ARRD)
  • Internal System Management including lot creation, batch status, and inventory maintenance
  • Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments
  • System and Non-system generated Shipments
  • Depot transfers
  • Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
  • Expected Document List (EDL) creation
  • eTMF Document Management per regulatory requirements
  • QA/QP Release Management
  • Pack-and-label kit and sequence reconciliation
  • Inspection Readiness activities
  • IRT management activities including IRT Alert management and UAT activities
  • Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management
  • Procurement support (Includes Work Order Management)
  • Vendor RFI support
  • Supply Planning & Inventory Management
  • Ancillary Supply Plan creation
  • Shipping & Logistics (Includes International Logistics requirements for Ancillaries)
  • Shipping & logistics activities
  • Temperature Excursions
  • Lot management
  • eTMF activities
  • ARRD activities
• Comparator Planning & Management
  • Market Intelligence Reports
  • Quote/PO/Requisition Process Support
  • IMN Creation
  • Document Storage
  • Temperature Excursions
• Financial Forecasting, Budgeting & Planning
  • Forecast Submissions
  • Order Ticket Entry
  • 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

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.