Senior Specialist, Clinical Supply Chain
Supply Chain Management | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, 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’s Supply Chain organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as Senior Specialist, Clinical Supply Chain. This role will be a hands-on role reporting to our Associate Director, Supply Chain & Logistics and is based at headquarters in South San Francisco, CA.
The role will partner closely with clinical study management teams to oversee clinical supply storage, packaging, labeling, distribution and reverse logistics associated with clinical trials. The Senior Specialist, Clinical Supply Chain will successfully manage these activities in conjunction with Supply Planning, Quality Assurance, and Allogene third-party service providers to ensure that clinical supply is available to meet trial demand. Responsibilities further include preparing metrics and monitoring operational performance across the clinical value chain.
Responsibilities include, but are not limited to:
- Manage daily order intake and distribution activities with all third-party service providers, ensuring right the first-time order submission and on-time delivery to clinics.
- Supports clinical study management team demand planning, distribution, inventory management, and execution of labeling operations at third-party service providers.
- Single point of contact for all clinical trial distribution activities throughout the duration of a study.
- Provide a responsive, effective and high level of customer service to Allogene’s Clinical Operations team.
- Author policies and procedures required for clinical supply chain activities to ensure GMP compliance.
- Support forecasting and capacity planning to ensure uninterrupted clinical supply.
- Pro-actively identify potential shipment delays and escalate as needed.
- Support selection, URS/UAT, configuration and management of clinical trial management E-Systems, IRT systems, etc.
- Perform root cause analysis associated with supply disruptions, including but not limited to transit delays, temperature excursions, etc.
- Participate in cross-functional distribution related projects and process improvement initiatives.
- Create and manage purchase orders and track budget adherence associated with clinical supply activities.
- Remain current with industry trends and best practices as well as changes in the regulatory landscape related to clinical supply chain.
- Other duties as assigned
Position Requirements & Experience:
- 2 to 3 years of relevant experience with an MS degree or 3 to 4 years of relevant experience with a BS/BA or 5+ years relevant experience with an AS degree. Degree in Business, Supply Chain Operations, or engineering field strongly preferred.
- Strong working knowledge forecasting clinical trial demand and 3PL supply strategy.
- Direct experience interfacing with clinical IRT systems; experience implementing a clinical IRT systems preferred.
- Demonstrated experience identifying, onboarding and managing 3PLs, including contract negotiation & budget oversight.
- Strong working knowledge of clinical packaging and labeling operations, as well as regulatory requirements.
- Working knowledge of import/export requirements associated with human derived clinical product to ex-U.S. locations preferred.
- Knowledge of cGMP quality systems.
- Understanding of drug product CMC activities.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.