Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early – to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.Candeltx.com for additional information.
This is an exciting time to join Candel Therapeutics as we are almost finished with construction for our first manufacturing suites/labs, and you will be one of the first employees to work in our new facility.
- Development and qualification of assays for characterizing and quantifying Adenovirus and Herpesvirus vectors and contaminants from process development, pilot, clinical, and commercial manufacture of Drug Substance and Drug Product
- Execution of analytical techniques such as cell and non-cell-based virus titration assays, potency assays, HPLC, electrophoresis, Western Blots, ELISAs, qPCR, sizing, and raw materials qualification testing assays
- Design and execute experiments, record, and analyze experimental data, propose conclusions, and recognize issues
- Participate in investigating and evaluating novel analytical technologies to improve current analytical programs
- Write and review technical development reports and provide project updates in written and oral presentations
- Interact with other departments such as upstream cell culture/viral vector production, downstream recovery and purification, manufacturing sciences, and quality assurance and provide analytics support to these groups
- Development of SOPs and batch records for use in the quality control group supporting the manufacturing facility or external CMOs for release of Drug Substance and Drug Product
- M.S. or Ph.D. in bio/chemical engineering, biochemistry, or related disciplines.
- 5+ years relevant experience preferably, including process development/manufacturing industry experience.
- Familiarity with basic regulatory expectations around product control strategies and the ICH guidelines for method qualification
- Familiarity with Drug Substance and Drug Product release and stability testing programs
- A strong background in one or more analytical techniques such as various HPLC based methods, microplate UV/Vis/Luminescent assays, cell-based assays including virus quantification and potency, qPCR, electrophoresis, sizing techniques such as DLS, etc.
- Ability to write technical documents, including but not limited to method SOPs, development reports, qualification reports, method transfer protocols and method transfer report
- Functional understanding of GxP principles is a plus
- Strong computer skills and good verbal and written communication skills
- Previous supervisory experience is a plus
- Very good collaboration and team building skills