Head of CMC Operations and Technical Leadership for Radiotherapeutic Development

5 days ago

San Diego, California, United States Z-Alpha Therapeutics Full time
Job Description:

Z-Alpha Therapeutics, a pioneering pharmaceutical company based in San Diego, is at the forefront of radiotherapeutic innovation. As a key player in the industry, we are dedicated to harnessing cutting-edge technology to revolutionize cancer treatment.

We are seeking an exceptional individual to assume the role of Head of CMC Operations and Technical Leadership for our radiotherapeutic development program. This high-profile position demands a visionary leader who can drive strategic growth, ensure seamless execution, and uphold rigorous quality standards.

Key Responsibilities:
  • Provide technical leadership and oversee CMC operational management for drug substance and product development from preclinical through commercial stages.
  • Evaluate and select third-party manufacturers, collaborating closely with Quality Assurance and Regulatory Affairs teams to negotiate optimal supply agreements.
  • Develop and manage relationships with external contract development and manufacturing organizations (CDMOs), ensuring compliance with regulatory requirements and upholding quality standards.
  • Work harmoniously with cross-functional teams to advance technical research and development initiatives.
  • Leverage expertise in process development, radiopharmaceutical synthesis, and GMP manufacturing to drive the creation of innovative radiotherapeutic products.
  • Oversight of external CDMOs' manufacturing operations to guarantee timely delivery of high-quality drug products for clinical trials and commercialization.
  • Ensure effective scale-up and transfer of GMP manufacturing processes to meet growing demand.
  • Drive the identification and implementation of process improvements to support evolving manufacturing needs.
  • Author, review, and approve Standard Operating Procedures, specifications, reports, and regulatory submissions as required.
  • Contribute to critical sections of the Investigator's Brochure (IB) and Common Technical Document (CTD).
Qualifications:
  • Ph.D. in Organic Chemistry, Radiochemistry, or a related field, coupled with 15+ years of direct experience in biopharmaceutical development, with increasing responsibility.
  • Extensive background in the pharmaceutical industry, with specific expertise in CMC development and progression of programs through clinical phases.
  • Radiopharmaceutical drug substance and product development experience, including quality control, is highly desirable.
  • Analytical chemistry skills, particularly in HPLC separation science, are essential.
  • A strong understanding of radiation safety regulations and guidelines is crucial for working with radiopharmaceuticals.
  • A successful track record in selecting and managing CROs/CMOs, including site qualification, technical transfer, clinical supply logistics, and oversight of activities.
  • Proven ability to write compelling CMC documents for regulatory submissions and a deep understanding of pharmaceutical development, quality, and regulatory matters.
  • Familiarity with GMP requirements and CMC regulatory expectations for radiotherapeutic and radiodiagnostic drug candidates is vital.
  • Exceptional leadership and interpersonal skills, with the ability to work collaboratively across CMC functional areas.
  • Strong knowledge of global CMC regulatory expectations, including cGMP, ICH, USP, JP, and experience in resolving complex issues with health authorities.
  • Experience authoring regulatory filings and interacting directly with Health Authorities.
  • Demonstrated flexibility in a fast-paced environment.
  • Excellent communication skills and the ability to thrive in a goal-oriented team setting.
  • Well-developed organizational skills to handle pressure effectively.
About Z-Alpha Therapeutics:

We are a world-class pharmaceutical company dedicated to delivering cutting-edge solutions in radiotherapeutics. Our vision is to pioneer novel treatments that enhance patient outcomes and improve lives.

Salary:

$250,000 - $350,000 per year, depending on qualifications and experience.

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