Associate Manager, CMC Supply Chain & Logistics

Manufacturing

Associate Manager, CMC Supply Chain & Logistics

Remote – Preference for Boston, MA; Austin, TX; Houston, TX areas

COMPANY BACKGROUND

Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches for patients with cancer and diabetes. Proprietary innovative gene therapy platform technologies are designed to develop our lead product candidate, REQORSA^TMImmunogene Therapy, to be administered with targeted therapies and with immunotherapies for NSCLC.

OVERVIEW

Genprex is seeking a motivated and experienced Associate Manager, CMC Supply Chain & Logistics to support supply chain and logistics of a novel oncology and diabetes focused portfolio. In this dynamic position, the candidate will have the opportunity to support internal project activities in concert with work outsourced to external partnerships. To ensure that materials are delivered as warranted by REQORSA™ supply needs, the candidate will oversee of the diverse contract manufacturing and testing organizations involved in the production of cGMP materials including drug substance, drug product and clinical supply chain. This position reports to the Director CMC Project Management & External Manufacturing and requires excellent collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. As we are an early-stage company, this is a highly visible and impactful role in our organization. The position will have the option of working remotely with a preference for candidates based in the Boston, MA; Austin, TX; or Houston, TX areas.

JOB RESPONSIBILITIES

1. Supply Chain and Logistics Management

• Supporting the management of Supply Chain and Logistics coordination of all CMC shipments, ensuring the successful delivery of cGMP materials including drug substance, drug product, clinical supply chain, and in process production materials (i.e. vials, filters, etc.)
• Collaborate with internal and external stakeholders to ensure timely manufacture, test, and release of batches as well as maintaining adequate inventory while monitoring expiry.
• Direct communications with internal CMC Manufacturing, Quality Assurance, Quality Control, etc., regarding supply, demand, and scheduling issues.
• Logistics specifics include – Initiation of inbound and outbound shipping forms for various domestic and global vendors; initiation of inbound and outbound shipping, customs, TSCA, USDA, etc. for multiple global couriers and import/export compliance; tracking of shipments, initiation/investigation of deviations, initiation of resulting CAPAs, willingness to acquire global shipping/logistics licenses, etc.
• Asset inventory management at all CDMOs, CMOs, CROs, and other suppliers.
• Assist in supply chain strategy
• Support the movement to Asset Inventory/LIMS software system. Includes working with Quality Assurance, Quality Control, Finance, Clinical, and Operational Teams to transition into system and assist in vendor implementation and validation.
• Support Finance department in development of quarterly asset inventory reports

2. Operational Excellence

• Maintain comprehensive communications to manager, providing real-time statuses of logistics and supply chain project, aligning with integration into the project and program plans.
• Facilitate discussions to gain alignment toward goals, set priorities towards expanding the development and commercialization of gene therapy assets.
• Proactively identify and drive continuous improvement opportunities

QUALIFICATIONS

• BS degree in life sciences, engineering, or related discipline with a minimum of 3-5 years relevant industry experience.
• Proficient knowledge of Microsoft Excel, PowerPoint, software.
• PMP certification a plus, with hands on experience using Smartsheet, Quality Management Systems, LIMS systems, etc.
• Understands the pharmaceutical drug development process. Working knowledge of biologics and gene therapy a plus.
• Knowledgeable with FDA, EMEA, ICH and other relevant CMC/Quality regulations and guidelines; knowledgeable of GxP requirements; knowledge of IND/CTA/BLA filing
• Strong project management, interpersonal, presentation and communication skills.
• Ability to partner with the business functions to enable high-quality outcomes.
• Self-motivated, ability to excel in fast paced biotech environment, problem-solving, critical thinking, negotiation and multi-functional influence abilities, and business process improvement and excellent prioritization skills.

Genprex is committed to providing an environment of mutual respect where equal opportunity and diversity are embraced and recognized as crucial to our success. We welcome diverse backgrounds, perspectives, and skills in our workforce and our culture.

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