Chemistry Manufacturing & Controls
Manager, Clinical Supply Management
Office Location: San Diego, CA or Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This function is responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for Arrowhead Pharmaceuticals clinical development programs.
This role is based in onsite with an expectation to be in the office five days a week.
Responsibilities
- Collaborate cross-functionally with Clinical Development, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, utilization forecasting, inventory control, and international shipments and external depot management for Phase 1-4 international clinical studies
- Develop clinical supplies distribution plans based on program and study timelines, trial design, recruitment, geography, and manufacturing schedules
- Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of study execution
- Serve as the primary point of contact cross-functionally for clinical supplies planning, inventory monitoring, and distribution, and third-party service provider/depot selection and oversight
- Coordinate with Manufacturing Operations, Quality Assurance and Regulatory Affairs to ensure planned IMP release testing/re-testing, stability, expiry dates, labeling and packaging schedules align with program milestones, adjusting as necessary over the course of the program
- Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements
- Serve as internal subject matter expert on fit-for-purpose labeling and packaging design options best suited to meet study requirements
- Serve as liaison between Clinical Operations and Quality Assurance to manage IMP stability parameters, temperature deviation management, product complaints and associated investigations
Requirements
- 4-year college degree (relevant discipline preferred)
- Experience with electronic interactive response technologies for inventory management
- Experience with managing supply for clinical investigations of injectables and biologics
- Solid vendor management skills
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
- Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and distribution
- Proficient in MS Officer (Word, Excel, and PowerPoint)
- Ability to work in a team or independently
- Effective interpersonal, written, and verbal communication skills
- Able to critically evaluate and prioritize job tasks and the impact on overall study execution
- Strong problem-solving capabilities
- Effectively collaborates with Study Team members
- Exceptional organizational skills with the ability to multi-task and prioritize
- Attention to detail
- Ability to work with distributed team members and outside vendors
Preferred
- Experience in multiple therapeutic areas
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.