Clinical Pharmacy Specialist Jobs

The Clinical Manufacturing & Supply Chain Specialist will work as an integral member of the Aimmune Clinical Manufacturing & Supply Chain Operations team, supporting and coordinating assigned aspects of Investigational Medicinal Products (IMP), Investigational Nutritional Products (INP), Clinical Trial Materials (CTM) and ancillary products used in Allergy (OIT, Biologic, etc.), Gastrointestinal (GI) or other clinical trial indications as added

Responsibilities

• Monitors schedule adherence of production schedules and makes course corrections if needed.
• Review and /or coordinate obtaining approvals of related technical documents such as clinical label text, clinical- packaging master batch records, clinical trial protocols and pharmacy manuals
• Minimal travel on company business may be required
• Maintains GMP inventory reports throughout the applicable supply chains, generates inventory reports, tracks upcoming expiry, and assists in conducting final drug accountability at study end.
• Provide general Clinical Manufacturing and Supply Chain support to other projects and products, as assigned.
• Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality Assurance, Product Development and CMC functions to ensure customer satisfaction
• Maintains an accurate, effective, and efficient clinical material tracking for all active clinical trials assigned
• Provides recommendations on packaging design, distribution, and blinding strategy.
• Coordinates and tracks bulk shipments to CMOs, depots, and vendors. Maintains and tracks import licenses renewals.
• Assists with monitoring and maintaining IWRS reports from IWRS and other sources to provide weekly drug projection and use visual inventory data.
• Executes supply and inventory plans and tracks production schedules for clinical trial materials.
• Gather data and maintain applicable Manufacturing and Supply Chain Operations metrics to monitor performance relative to clinical trial manufacturing, inventory, and planning.
• Working closely with Clinical Operations, Collaborators and Investigators, and clinical Packaging/Labeling groups ensures adequate clinical materials are available for ongoing or new clinical trials in timelines agreed.

Qualifications

• APICS CSCP or CPM certification preferred
• Bachelor's degree must be in science, engineering, or another relevant field
• Experience in a GMP manufacturing facility a plus
• Bachelor’s degree in Chemistry, Biology or Engineering and 2 to 4 years relevant work experience or a Master’s degree in Chemistry, Biology or Engineering and 1-year relevant work experience.