Director CMC

NeoTX is a private biopharmaceutical company developing pharmaceuticals that enhance the ability of the immune system to recognize and eliminate cancer

The company’s lead drug is a novel immuno-oncology biologic, in development for multiple indications, that has completed a several clinical studies and will be initiating phase II studies in Q1 2021 in combination with other immunomodulators. NeoTX has recently completed at $45MM Series C funding that has provided capital that will fund the current clinical program and the ongoing development of the product portfolio of large and small molecules.

The Director of CMC will be responsible for CMC-related activities across the portfolio including drug substance and drug product, process development, pre-formulation, formulation, pilot/feasibility manufacturing, and manufacture, including analytics. Responsible for assuring coordination of sourcing, assembly, supply and distribution of all clinical trial materials.  The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Principal Duties and Responsibilities 

•      Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for multi-national studies

•      Identification, selection, contracting and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) and all clinical supply materials in support of clinical programs

•      Projection of DS, DP and other clinical supply needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance)

•      Management of supply chain, timelines and logistics (including import/export of DS, DP and clinical trial supplies) in support of clinical studies

•      In coordination with Quality Assurance, implement stage appropriate analytical methods, protocols and validation, and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards

•      Management of stability program and logistics, including coordination of analyses for DS and DP

•      Writing and reviewing documents for clinical trial applications (IMPD, INDs / regulatory section submissions); represent the company as the CMC expert before Israeli, U.S. and European regulatory authorities

•      Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents

•      Evaluate and oversee implementation of strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs

•      Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile

•      Formulation design/development for clinical programs

•      Prepare technical reports, publications and presentations