What are the responsibilities and job description for the Head, CMC Radiopharmaceuticals - Oncology position at Z-Alpha Therapeutics?
Recruiters Please Do Not Contact
Z-Alpha Therapeutics is a San Diego based pharmaceutical company dedicated to the discovery and development of radiotherapeutics targeting key biological pathways for solid tumors. The company has a revolutionary technology platform in the next generation of alpha particle therapy with potential to be a more targeted therapy, increasing efficacy and limiting toxicity compared to competitors in the radiotherapeutics space. The company has a world-class team of scientists with decades of experience and foundational intellectual property that enables the potential to bring multiple drug candidates into the clinic.
Summary :
We are seeking a highly motivated individual to head up the CMC function in support of Z-Alpha Therapeutic’s development of novel radiotherapeutics. The candidate will be responsible for phase appropriate CMC development and manufacturing strategies, due diligence, identifying and implementing necessary process improvements, oversight of activities at contract development and manufacturing organizations (CDMOs), and authoring and review of relevant submissions to regulatory agencies.
Responsibilities :
- Responsible for the technical leadership and CMC operational management and process development for drug substance and drug products from pre-clinical through commercial.
- Identify and evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply / technical agreements.
- Drive selection and management / oversight of synthetic and analytical laboratory site(s) required to guide and support third party manufacturing relationships.
- Work collaboratively with functional management in technical research and development.
- Provide technical and strategic leadership for the process development of radioactive drugs including radionuclide production and purification, and either drug radiosynthesis (small organic molecule candidates) or prosthetic agent synthesis and radiolabeling, and linker-conjugation chemistry. This will include radiopharmaceutical drug substance, drug product, and final formulation.
- Oversight of proper execution of manufacturing runs at external CDMOs, ensuring supply for on-going and planned non-clinical studies and into clinical trials including all aspects of drug product development, drug delivery and drug product packaging and stability
- Accountable for the technical transfer and scale up of GMP manufacturing.
- Identification of necessary process improvements, and management of development / implementation of process improvements to support manufacturing requirements.
- Responsibility to develop, author, review, and / or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed.
- Contribute to relevant sections of the Investigator’s Brochure (IB) and common technical document (CTD).
- Contribute to building and maintaining clinical phase-appropriate Quality infrastructure in support of external CMC operations.
- Act as process and technical expert for CDMOs, ethics committees, and regulatory bodies, as applicable. Representation of the company as overall manufacturing process expert during diligence and partner company interactions.
Qualifications :
