Senior Manager, Packaging and Serialization

<div class="content-intro"><p></p> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow"><strong data-ogsc="" data-olk-copy-source="MessageBody">About Acadia Pharmaceuticals</strong></span></div> <div data-ogsc="black">&nbsp;</div> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow">Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.</span></div></div><p style="text-align: center;">Seeking talent near: Princeton, NJ; San Diego, CA</p> <p>&nbsp;</p> <p><strong><u>Position Summary:</u></strong></p> <p>Responsible for coordination of packaging (package design), artwork, and serialization with commercial Drug Product Contract Manufacturing organizations (CMO’s), and other third party suppliers for products as identified. Subject matter expert in the field of serialization to oversee our CMOs running commercial and Acadia data management and integration.</p> <p>Experienced in the technical aspects of product introduction into the EU and other global markets as related to serialization, package design, and local requirements.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Develops and maintains good working relationships with both internal stakeholders and contract manufacturers.</li> <li>Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) serialization technologies to ensure our CMOs are aligned. Verifies CMO serialization technologies and ensures compliance with pharmaceutical regulatory requirements (EU FMD and DSCSA).</li> <li>Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.</li> <li>Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.</li> <li>Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.</li> <li>Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Event