Director/Senior Director, Supply Chain Operations and Logistics
Supply Chain Management | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a highly motivated individual with distribution, logistics, warehousing, cold chain, and related biotechnology/pharmaceutical industry supply chain experience that will directly support Allogene’s goal of commercializing allogeneic T cell therapy for cancer treatment. As the Director/Senior Director, Operations and Logistics, you will be a key member of the Supply Chain Leadership Team and you will interface with a diverse team across Clinical Operations, Manufacturing, Supply Chain, Quality and external partners to support key tasks related to planning, shipping & logistics, labeling, packaging and distribution of clinical materials for multiple clinical trials.
Responsibilities include, but are not limited to:
- Lead global oversight of storage, distribution, packaging, labeling, cold chain and transportation of Allogene cell therapies
- Coordinate deliveries between manufacturing sites and Allogene’s 3PL providers
- Support the development and implementation of ERP systems for inventory management and planning
- Develop inventory and planning reports including inventory reconciliation at 3PL provider
- Support the evaluation, selection and quality audit of logistic providers
- Evaluate shipping lanes, shipping configuration, and other logistic related activities
- Coordinate Import/export activities
- Work with Clinical Operations to ensure adequate communication process with clinical sites per study in regard to allogeneic CAR T just-in-time shipments
- Serve as internal lead for triaging of product complaints, temperature excursions, etc. originating from clinical sites. Investigate deviations to determine root causes and implement corrective actions
- Coordinate review and approval of labeling
- Maintain and track import / export licenses
- Create standard operating procedures
- Perform other duties as assigned
Position Requirements & Experience:
- Bachelor’s Degree in Life Sciences is required with a certification in logistics or planning preferred
- 10+ years of relevant logistics, planning, or supply chain experience, in a pharmaceutical or biotech company
- Understanding of global pharmaceutical regulatory requirements. Knowledge of global clinical trials and the drug development process. Experience in cell and/or gene therapy preferred.
- Experience working effectively with cross-functional teams in a fast-paced, dynamic environment
- Experience in the development, implementation and use of ERP systems a plus
- In depth knowledge of material requirements planning and production scheduling
- Demonstrated technical skills and mindset in logistic and cold chain management including process optimization and delivery of drug product
- Knowledge and understanding of international pharmaceuticals shipping requirements
- Additional specific qualifications in clinical supplies demand and logistics/ or planning management including and APICs, CPIM, and related processional certifications preferred
- Self-motivated and willing to accept responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.