Senior Manager, Translational Sciences Operations
Translational Sciences | 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 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 is seeking a highly motivated individual with planning, logistics 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 Senior Manager, Translational Sciences Operations, you will have a highly cross-functional role that interfaces with a diverse team including Translational Sciences, Clinical Development, Clinical Operations, Regulatory, Supply Chain, Quality Assurance, and external partners to support key tasks related to Translational Science operational processes including clinical sample management and logistics strategy and implementation. You will provide biomarker operational expertise and guidance to the internal team as well as external partners.
Responsibilities include, but are not limited to:
- Sample management coordination, including associated materials management, transportation, cold-chain distribution and logistics.
- Serve as the project lead accountable for evolving the current-state sample management process into an automated systems-based platform for tracking and distribution of clinical samples with varied shipping requirements
- Partner with Translational Sciences, Clinical Operations, Supply Chain, Quality Assurance and representatives from external labs to define the processes and controls required for biological sample collection to remain in compliance with trial protocol, GCP, and applicable regulatory requirements
- Develop service level agreements with external partners and internal customers; monitor and measure service level adherence.
- Support the development and implementation of IRT/CTMS/LIMS related systems.
- Support the evaluation, selection and quality audit of logistic providers.
- Partner with Supply Chain to evaluate shipping lanes, shipping configurations, and other logistics related activities that support sample management.
- Coordinate Import/export activities with qualified transport service providers.
- Develop communication plans to ensure adequate escalation and communication pathways are in place with clinical sites, labs, and internal customer groups.
- Ensure all necessary documentation is available to sites.
- Serve as internal lead for triaging temperature excursions or service level interruptions; lead investigations associated with deviations and implement corrective actions as applicable.
- Create standard operating procedures (SOPs) and/or statements of work (SOWs) as applicable.
- Participate in the creation of the Supply Chain of the future.
- Perform other duties as assigned
Position Requirements & Experience:
- Bachelor’s Degree in Life Sciences, project management or related business administration is required with a certification in logistics or planning preferred
- 5+ 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
- 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
- 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
- Demonstrated ability to apply knowledge and skill set to solve novel and rapidly evolving challenges
- Detailed oriented with excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
- Strong work ethic, self-motivated and willing to accept responsibilities outside of initial job description
- 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.