Specialist/Sr. Specialist, Clinical Manufacturing & Supply Chain
Aimmune Therapeutics
Operations
Remote
Posted on Friday, April 8, 2022
Position: Specialist/Sr. Specialist, Clinical Manufacturing & Supply Chain
Reports to: Associate Director, Clinical Manufacturing & Supply Chain • Clinical Manufacturing
Location: Remote – US
Reports to: Associate Director, Clinical Manufacturing & Supply Chain • Clinical Manufacturing
Location: Remote – US
Summary: 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.
Specific Responsibilities:
- Executes supply and inventory plans and tracks production schedules for clinical trial materials.
- Monitors schedule adherence of production schedules and makes course corrections if needed.
- Maintains an accurate, effective, and efficient clinical material tracking for all active clinical trials assigned
- 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
- 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.
- Coordinates and tracks bulk shipments to CMOs, depots, and vendors. Maintains and tracks import licenses renewals.
- Provides recommendations on packaging design, distribution, and blinding strategy.
- Assists with monitoring and maintaining IWRS reports from IWRS and other sources to provide weekly drug projection and use visual inventory data.
- Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality Assurance, Product Development and CMC functions to ensure customer satisfaction
- 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.
- Provide general Clinical Manufacturing and Supply Chain support to other projects and products, as assigned.
- Minimal travel on company business may be required
Qualifications / Requirements:
- 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.
- Bachelor's degree must be in science, engineering, or another relevant field
- APICS CSCP or CPM certification preferred
- Experience in a GMP manufacturing facility a plus
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.