Sr Clinical Supply Operations Specialist
Regeneron Pharmaceuticals
Summary
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.
Job description
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: 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.
Requirements
- BS/BA degree in a related field
- Minimum of 3+ years of experience in Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, Manufacturing, or equivalent research/commercial biopharma experience
- 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.