Head of CMC for PokeAcell
– Join our new biotech developing curative cell therapy to late stage cancer –
Are you dreaming of shaping a new biotech company and developing curative treatment to cancer? Are you highly experienced in CMC product development from biotech or large pharma and want to use your capacity to catalyze a new cell therapy to cancer? – then read on.
PokeAcell is a newly establish biotech company with a proprietary technology for personalized T-cell therapy preparing for phase I in melanoma. We are an experienced team of science and business leaders founding PokeAcell with the vision to provide curative treatment to late stage cancer patients, where no treatment is available today. Our T cell therapy hold the promise of curative treatment in Melanoma and Merkel Cell carcinoma – two of the most severe skin cancers today and with potential in several other indications.
We are looking for a highly experienced head of CMC to lead our CMC product development and shape PokeAcell as a company to deliver curative treatment to patients soon. Your core responsibilities will be to:
- Develop the CMC control strategy and development plan
- Front the CMC discussions with regulatory authorities
- Establishing the supply chain from raw materials to personalized therapeutic cell product
- Lead a growing team within CMC
In addition, you will build PokeAcell together with us as the founders to establish a professional and cutting-edge cell therapy company. The job is located in Copenhagen with some activities taking place at DTU in Lyngby.
You have a senior profile and the capacity to create a clear CMC path for a new technology in a field with only emerging regulatory guidance. You have the ability to be pragmatic and think outside the box and use this to develop an effective path to market. You have a desire to shape PokeAcell in its mission to deliver curative treatment to cancers and get things done – big and small – to bring the development ahead.
More specifically, you have a relevant scientific Master degree or PhD; 10+ years of CMC experience; experience in developing CMC plans for new products from phase I to commercialization – ideally within biologics at appropriate quality level and experience in writing regulatory documents and fronting CMC discussions with EMA and FDA. Ideally you have worked in several CMC fields and have cross functional experience from QA, RA, project management etc.
We offer you to become part of a fun and professional team, shaping the future of PokeAcell and creating curative treatment to cancer patients. Give us a call to discuss more if your heart is beating faster than usual and you are ready for a new endeavor.
Reach out to CEO Anne Reker Cordt at +45 53393007 or ARC@pokeacell.com. We prefer applications before March 15.
Read more at www.pokeacell.com