Sr. Supply Chain Specialist – Atara Biotherapeutics – Los Angeles, CA, USA
We launched Atara Biotherapeutics in August 2012 to help patients combat cancer, kidney disease and other illnesses. Our research is based on groundbreaking discoveries regarding the ability of activin, myostatin and other growth factors as well as allogeneic, or third-party derived, antigen-specific T-cells, to change the course of disease progression. Our goal is to help patients such as Atara Ciechanover, our company’s namesake, who suffered from cancer before passing away in 2012. We aim to empower patients to fight their illnesses with better treatment options.
Position Summary
The purpose of this position is to support all manufacturing and supply chain activities for the development of the company’s investigational products. Responsible for the end-to-end supply chain of company products in support of clinical trials and commercialization.
Location: Westlake Village, California
Reports to: Technical Manager of Technical Operations.
Primary Responsibilities
- Develops and manages end-to-end T-cell supply chain process and logistics to ensure seamless supply of starting materials and intermediates from donation sites through delivery of on time critical final product to clinical sites.
- Develops and manages end-to-end supply chain process and logistics for all protein related products to ensure seamless supply of investigational material through delivery of on time final product to clinical sites.
- Leads cross-functional teams through product demand forecasting and build manufacturing plans to supply clinical trials, and maintain adequate safety stock.
- Coordinates with internal teams/stakeholders, strategic partners and CMOs to ensure product manufacturing strategy is clear and aligned.
- Responsible for T-cell therapy intermediates and final product planning, scheduling and shipments between donation sites, CMOs and clinical sites. Ensure all required shipping documentation, safety, import/export licensing and any associated pre-approvals are completed and provided to appropriate senders/consignees to support on-time delivery. Ensure all required shipment conditions are met according to material specifications. Coordinates with Quality on any shipment-related deviations, investigations and CAPAs.
- Reconciles material transactions and is responsible for the inventory management system.
- Promptly identifies, escalates and resolves issues and mitigates risks to study timelines and/or clinical supply.
- Develops and owns logistics policies and procedures for supply chain operations and related activities.
- Develops, executes, and manage all distribution and shipping studies to support CMC and clinical product transportation.
Travel: Travel may be required (up to 15%).
Physical Requirements
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job.
Skills and Abilities
- Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
- General understanding of pharmaceutical development, clinical research, biologics manufacturing, cell therapy manufacturing, project management, and virtual CMO business model.
- Strong time and project management skills.
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
- Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
- Able to understand and interpret data/information and its practical application.
Education and Professional Experience
- Minimum of a Bachelor’s degree, preferably in Chemistry/Life Sciences/Health Related Sciences, from an accredited college or university.
- 5-7 years of related pharmaceutical, biopharmaceutical manufacturing, or cold chain supply chain/logistics industry experience, with at least 4 of those years directly in planning, manufacturing and global distribution of medicinal products. Experience in cell therapy or cell based product distribution practices is a plus.
- Strong Supply Chain Management acumen.
- Excellent knowledge and experience of CMO activities.
- Proficient in pertinent software & tools such as MS Project, Excel, Word, SharePoint, and Power Point.
- Experience with ERP systems including working with user requirements and implementation teams.
- Must be knowledgeable and worked in biotech manufacturing related industry.
- APICS CPIM/CSCP certification
