Radiopharmaceutical Process Development Lead

6 days ago


San Francisco, California, United States Abdera Therapeutics Full time
About Abdera Therapeutics

Abdera Therapeutics is a precision oncology company dedicated to developing next-generation targeted radiation therapies. Our proprietary modular technology platform enables the rapid development of safe and efficacious therapies for cancer patients with limited treatment options.

Job Summary

We are seeking an Associate Director of Radiopharmaceutical Process Development to drive the CMC radiopharmaceutical process development for our novel clinical programs. The successful candidate will lead the development of cGMP compliant processes and clinical drug product specifications, manage the execution of CMC studies, and author drug substance/product IND sections.

Key Responsibilities
  • Lead the process development of radiopharmaceuticals for phase 1 clinical trials
  • Partner with a multidisciplinary team to select the appropriate CDMO for development and manufacturing of our novel product
  • Create technology transfer packages for CDMOs by translating pre-clinical analytical methods and drug product synthesis to processes suitable for clinical development
  • Design and execute studies to determine suitable process flow, process conditions, materials selection, and acceptable ranges
  • Partner with external/internal development labs to define IND enabling study protocols and review study run data
  • Lead the execution of process qualification and validation campaigns and prepare relevant reports and data for IND sections
  • Write relevant CMC sections and supporting reports for submission to regulatory agencies
  • Execute clinical readiness activities to enable clinical manufacturing
Requirements
  • MSc or PhD in scientific fields with 10+ years of experience in the pharmaceutical industry, including radiopharmaceuticals
  • Knowledge of cGMP requirements, aseptic process, and equipment qualification
  • Experience in writing CMC sections of regulatory submissions and clinical development and manufacturing in the biotechnology or pharmaceutical industry
  • Excellent written and verbal communication skills, strong analytical capabilities, and demonstrated critical thinking skills
About Us

Abdera Therapeutics is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit harassment of any kind and any form of discrimination based on protected characteristics.



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