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:
- PhD in Organic Chemistry, Radiochemistry or related field and 15+ years of direct related experience with increasing responsibility in biopharmaceutical development.
- Extensive experience in the pharmaceutical industry, with specific experience within areas of CMC development and with progression of programs through clinical development
- Radiopharmaceutical drug substance and drug product development experience and quality control is preferred
- Analytical chemistry and knowledgeable in HPLC separation science
- Working with radiopharmaceuticals with a good understanding of the radiation safety regulations and guidelines.
- A successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities.
- Must have experience in writing CMC documents for regulatory submissions and a strong understanding of pharmaceutical development, quality and regulatory issues.
- Hands on working experience with early stage of drug development, as well as in-depth knowledge and full understanding of GMP requirements and CMC regulatory requirements, principles and best practices for radiotherapeutic or radiodiagnostic drug candidates.
- Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively across CMC functional areas.
- Extensive experience with regulations and requirements such as cGMP, ICH, USP, JP and global CMC regulatory expectations and proven track-record of resolving complex issues with health authorities.
- Experience authoring regulatory filings and interacting directly with Health Authorities.
- Has demonstrated flexibility within a changing environment.
- Excellent communication skills and the ability to work in a goal and team-oriented setting.
- Well-developed organizational skills and the ability to thrive under pressure.
