Genprex
Manufacturing

Manager, CMC Project Management, Planning & Supply Chain

Remote (with preference for candidates in the Houston, TX, Austin, TX or Boston, MA 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™ Immunogene Therapy, to be administered with targeted therapies and with immunotherapies for NSCLC.

OVERVIEW
Genprex is seeking a motivated and experienced Manager / Senior Manager CMC Project Management, Planning, and Supply Chain to support the tactical and operational aspects of novel oncology and diabetes focused portfolio at all stages of pre-clinical and gene therapy clinical development. In this dynamic position the candidate will have the opportunity to orchestrate 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 provide oversight 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 directly to the Chief, Manufacturing and Technology Officer.

The candidate should have proven experience in the implementation of strategic initiatives in a dynamic business environment, a solid technical background, project and portfolio management and understand the many facets of biologics clinical development as well as the challenges and impact of identifying, selecting, and managing CMO partners. The incumbent will have managed external Contract Development and Manufacturing Organizations (CDMOs) in the clinical supply chain and ensure that all supply partners are using systems and processes in compliance with the latest and most relevant global regulatory standards.  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

  • Plan and coordinate project management aspects of multiple external operations including relationship management, contract oversight, budget negotiation and reporting, risk assessment, maintenance of projects plans, supply chain, and the implementation of performance governance and relevant KPIs.
  • Create cohesive project plans of internal programs from early pre-clinical development to commercialization integrating all CMC activities, including both internal and external activities.
    Provide support in CMC development strategies and operational plans across the Genprex portfolio, orchestrating analytical, process, formulation development and supply chain management.
  • Ensure CMC Project plans are aligned with Genprex corporate strategy and timelines, utilizing MS Project, / Smartsheets, and enterprise systems to enable timely and effective communication, building scenario and mitigation plans that foster decisive decision making.
  • Maintain CMC related project plans including tasks, timelines, and resources; ensure projects are delivered as required within the expectations of quality budget and project standards
  • Organize cross-functional CMC development Project Teams with infrastructure for decision/action logs, dashboards, etc., includes planning, coordinating, and overseeing PM activities.
  • Maintain the dashboard and provide status updates for regular portfolio meetings ensuring development and implementation of efficient operations and cost-effective solutions.
  • Facilitate discussions to gain alignment toward goals, set priorities towards expending the development and commercialization of gene therapy assets.
  • Provide leadership to plan, organize, direct, coordinate and control all manufacturing & Operational logistics; implement the plans to achieve business goals required to manufacture, deliver and test products within budget and contractual standards in accordance with the defined quality standards.
  • Collaborate with internal and external stakeholders to ensure timely manufacture, testing, and release of batches as well as adequate inventory
  • Proactively identify and drive continuous improvement opportunities and effectively lead timely resolution of production issues including working with Quality Operations and CMOs to resolve change controls, deviations, and CAPAs.
  • Assist in the preparation and technical review of regulatory CMC documents.

QUALIFICATIONS

  • BS or MS degree in life sciences, engineering, or project management with minimum of 2- 5 years relevant industry experience preferred
  • Demonstrated ability and hands-on experience in biologics CMC Project Management and coordinating CMC process development, technology transfer, GMP manufacturing, and supply chain.
  • PMP desired, with hands on experience using MS Project, Smartsheets, SAP / Oracle for supply chain, and Quality Management Systems (e-Doc, Track wise etc.)
  • Experience in managing CDMOs and oversight of cGMP manufacturing activities.
  • Significant knowledge of drug substance and drug product manufacturing processes.
  • Have a track record in devising and implementing CMC strategies from concept phases through GMP manufacturing for development candidates.
  • Knowledgeable with FDA, EMEA, ICH and other relevant CMC/Quality regulations and guidelines; Experience with IND/CTA/BLA filing.
  • Strong project management, interpersonal, presentation and communication skills.
  • Ability to partner with the business functions to enable high-quality outcomes.
  • Travel to various sites required, particularly during production campaigns.
  • 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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