Associate Director, Site Supply Chain - Cell Therapy - Neogene Therapeutics
Santa Monica, CA
About the Job
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary
The Associate Director, Site Supply Chain will oversee supply chain operations for our allogeneic cell therapy product and manufacturing site. You will start up the operations to manage the end-to-end supply chain activities related to allogeneic cell therapy products, ensuring the delivery of high-quality products to patients while maintaining compliance with regulatory standards. You will be based in Santa Monica, CA and report to the Vice President of Supply Chain.
Responsibilities
- You will create and execute allogeneic cell therapy supply chain processes for:
- Demand and supply planning: collaborate with teams to forecast demand and develop production supply plan to meet clinical trial requirements
- Inventory management of Raw Materials, Gene Editing Tools and Final Product: optimize inventory levels to ensure uninterrupted development, production and patient supply
- Healthy Donor starting material and supplier management: oversee supplier relationship and manage unique planning requirements for allogeneic patient starting material
- Labeling and Packaging: determine final product cryogenic labeling, packaging and shipping solutions
- Storage, logistics and distribution: determine allogeneic final product storage and logistics to the clinical site. Contribute to the Investigational Product Handling Manual and training.
- You will create and start up brand new manufacturing site supply chain processes for Materials Management, Warehouse, Product Distribution, Production Scheduling, and other site operations
- You will ensure raw material GMP readiness, including new materials risk framework, risk assessment and mitigations for allogeneic cell therapy requirements
- You will author site supply chain SOPs, work instructions, and management tools for managing site supply chain operations.
- You will set up ERP system and master data readiness for warehouse and inventory management
- You will support tech transfer, launch of clinical trial and new facility readiness
- You will have future managerial responsibilities
Education and Experience
- 8+ years' experience with BS/BA OR 6+ years with MS/MA or MBA, OR 3+ years with PhD
- Direct experience and working knowledge in the pharmaceutical or biotech industry, with experience in supply chain logistics and planning, manufacturing site supply chain experience, and preferably cell therapy experience
- Knowledgeable with cGxP for cell therapy and pharmaceutical industry.
- Experience using inventory management, asset management and environmental monitoring systems such as ERP (Netsuite), CMMS (Blue Mountain) and EMS (Vaisala).
The annual base pay for this position ranges from $114,838 to $157,902. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.