The successful candidate will have a strong scientific background, as well as hands-on expertise creating and troubleshooting purification procedures for protein-based biologic products. In order to design scalable, robust, and effective procedures, the candidate must also have experience scaling up/down, tech transfer, and a thorough understanding of cGMP.Key Responsibilities
- Assist the Protein Discovery team as a subject matter expert in the development of protein purification processes. Create procedures and documents such as batch records, summary reports, and technical reports.
- Design and carry out experiments, collect and analyze data. Present process analyses, trends and summaries to the group in a timely manner.
- Generate, enhance and enrich process understanding knowledge. Initiate novel process/technology when applicable.
- Assist with cell culture and in-process analysis work when needed.
- Make strong technical contributions to cross functional development project teams to ensure efficient and timely execution of deliverables.
- Collaborate with other teams and CDMO partners in designing manufacturing processes and assist with tech transfer activities.
- Contribute to relevant sections of IND filings and other documentation.
- A bachelor's degree in a relevant field of study with at least ten years of industry experience, a master's degree in an applicable subject of study with at least eight years of industry experience, or a doctorate in an applicable field of study with at least five years of industry experience.
- The successful candidate will be versed in DSP's chromatographic, normal, and tangential filtration devices, as well as related software.
- AKTA Avant or Pure experience.
- DSP related process analytics experience in process performance, protein quality and residuals.
- Experience with Fc fusion proteins is strongly preferred as well as experience with monoclonal antibodies.
- Protein formulation experience is a plus. Knowledge of DS and DP process desired.
- DOE experience is strongly preferred.
- Experience with statistical software such as JMP or Minitab.
- Understanding of QbD is a plus.
- Cell culture experience or knowledge is a plus.
- Experience with cGMP collaboration, including technical review, is desired.
- Strong drive and interest in developing a novel therapeutic protein class