Our client, a multinational therapeutic company, has a leadership opportunity for a talented downstream process development scientist experienced in biologics, especially vaccines. This person will lead both people and projects in a company with strong career development. Multiple projects from an expanding pipeline will keep you learning and growing, personally and professionally. You will work cross-functionally with upstream process development, regulatory, manufacturing, even commercial development. You will contribute to INDs by writing the CMC portions and be involved in tech-transfer for clinical production. You may also lead, train, and mentor junior scientists at all levels. Other duties include:
- Evaluating incoming new projects from the research team
- Evaluate, develop and optimize the process parameters for downstream purification.
- Troubleshoot issues related to the process and product.
- Use DOE software to design the experiment, analyze the results
- Write technical reports and transfer methods to clinical or commercial manufacturing
- Guide/train junior level scientists
To be considered, you will need:
- A PhD with 5+ years experience or an MS degree with a minimum of 15 years’ relevant industry experience
- Master or Ph.D of Science/engineering in Biology, chemistry, chemical engineering, or related discipline
- Downstream experience is necessary including Chromatography Purification and Diafiltration/Ultrafiltration experience
- Design of Experiment (DoE) experience
- Scale down/scale up knowledge
- Strong trouble shooting and data analysis skills
- Good writing skills
- Good communication skills
Preferred Experience includes
- Downstream process development of viruses or VLPs
- Experience with IND and BLA is preferred
- Engineering knowledge/hands-on experience troubleshooting equipment issues
- Upstream process knowledge
- Protein chemistry knowledge
- Good aseptic technique
To apply for this position, confidentially email us here.