Company: Innovative Biotechnology Company
Job Title: Associate Director or Director of Radiopharmaceutical Development
Location: California, USA
Salary: $165,000 – $210,000 plus an attractive bonus and equity
Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.
Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!
Company Summary:
Our client is an innovative Oncology biotechnology company developing next-generation targeted radiation therapies - one of the most talked about areas of drug development. You will be part of a successful small company and R&D team, working with likeminded individuals who are using an innovative modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells, while sparing healthy ones. With a recent IND and another due to be finalized shortly, and a promising pipeline, you will be working for a successful precision oncology company and be part of history.
Responsibilities:
- Lead the process development of radiopharmaceuticals for phase 1 clinical trials
- Select and manage CDMO vendor partnerships for the development and manufacturing process
- Lead all Drug Substance and Drug Product to IND submission
- Create technology transfer package for CDMO’s by translating pre-clinical analytical methods and drug product synthesis to processes suitable for clinical development
- Write relevant CMC sections and supporting reports for submission to regulatory agencies (IND to the FDA)
- Represent CMC, act as the liaison to partner with research radiochemistry and in-vivo team to share best practices and facilitate knowledge exchange
Qualifications
- 10+ years' experience in the Biotechnology or Pharmaceutical industry, coupled with a MSc or PhD in a scientific field
- Radiopharmaceuticals experience, ideally in clinical trials
- Technical working knowledge of the bioconjugation of antibodies
- Knowledge of cGMP requirements and equipment qualification
- Experience in writing CMC sections of regulatory submissions
- Good understanding of the radiation regulations and guidelines
Successful job hire will include a competitive salary, bonus and benefits