Supply Chain Specialist

ADARx Pharmaceuticals Inc.•San Diego, CA

5d•Onsite

About The Position

We are seeking a highly motivated and qualified individual to join our CMC Department as a Supply Chain Specialist and work as part of a team to drive success. The Supply Chain Specialist, Clinical Supplies will support the planning, coordination, and execution of global clinical supply activities for company-sponsored clinical trials. This role will partner cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to ensure uninterrupted supply of investigational product (IP) to clinical sites while maintaining compliance with GxP, regulatory, and company requirements. The ideal candidate is detail-oriented, highly organized, and experienced in managing clinical supply logistics in a fast-paced pharmaceutical or biotech environment.

Requirements

Bachelor’s degree in supply chain, life sciences, or related field.
BS with 3 years of experience or MS with ½ years of experience in clinical supply chain, clinical operations, or pharmaceutical logistics.
Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
Working knowledge of GxP requirements and global clinical trial supply practices.
Experience coordinating with CMOs, depots, and third-party logistics providers.
Familiarity with IRT/RTSM systems and clinical supply management tools.
Strong organizational skills with the ability to manage multiple studies and priorities simultaneously.
Proficient in Microsoft Office (Excel, Word, PowerPoint); experience with ERP or inventory systems preferred.
Must be able to work independently with supervision as needed.
Proficient at working independently as well as in cross-functional team settings
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
Strong problem-solving skills and a proactive attitude towards exploring new approaches.
Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.

Nice To Haves

Experience supporting global, multi-site clinical trials (Phase I–III).
Understanding of temperature-controlled shipping and cold chain management.
Experience with import/export documentation and international shipping regulations.
Prior experience in a small to mid-size biotech or fast-growing pharmaceutical company.

Responsibilities

Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability.
Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner.
Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
Support end-to-end clinical supply chain activities including forecasting, planning, packaging, labeling, distribution, returns, and reconciliation of investigational product.
Coordinate with internal stakeholders and external CMOs, depots, and logistics vendors to ensure timely manufacturing and delivery of clinical supplies.
Maintain and track inventory levels at depots and sites; proactively identify and mitigate potential supply risks.
Generate and manage clinical supply forecasts and resupply strategies based on enrollment projections, drug product expiry dates, and study timelines.
Support creation and review of packaging and labeling specifications in alignment with study protocols and regulatory requirements.
Manage Interactive Response Technology (IRT/RTSM) supply settings and ongoing updates in collaboration with Clinical Operations and vendors.
Prepare and review shipment documentation and ensure compliance with import/export and country-specific requirements.
Reconcile clinical supplies, including returns, destructions, and accountability documentation.
Contribute to development and continuous improvement of SOPs, work instructions, and supply chain processes.
Ensure all activities comply with GCP, GMP, and applicable regulatory guidelines.
Maintain accurate documentation and support audits and inspections as needed.
Provide Operational support services to CMC development and manufacturing functions.
Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level.
Maintain all appropriate corporate standards for facility safety and hazardous material management.
Other duties as assigned.