Palleon Pharmaceuticals is seeking a talented individual to fill the position of Sr. Scientist, Process Analytics. S/he will report to the VP of CMC and will play a key role in using state-of-the-art analytical techniques to support process development, including cell culture, purification, and formulation development. S/he will also contribute to protein biochemical/biophysical characterizations, material comparability studies, stability studies, technology transfer, and manufacturing process support. S/he must have a strong background in analytical assay development, protein biochemistry and process characterization, and a good understanding of biotherapeutic product development in general.
- Develop analytical methods for protein product characterization including purity, quantity, enzymatic activity, biochemical and biophysical properties, and structural/functional analysis.
- Design and execute analytical tests for raw materials identification, process intermediates characterization, and process impurity analysis.
- Investigate and mitigate protein instability during the manufacturing process, and conduct material compatibility and stability studies under real-time or accelerated conditions.
- Closely interact with discovery, development, and CRO for process development, technology transfer, and process implementation.
- Provide technical support for GMP and/or non-GMP manufacturing activities, including deviation investigation and process change.
- Write and review study protocols, technology transfer documents, and manufacturing batch records, and present study data to both internal and external audiences.
- BS/MS degree in relevant scientific discipline with 10+ years of industry experience, or PhD with 3 – 7 years of industry experience.
- Strong scientific expertise and hands-on experience in protein characterization using different techniques, including HPLC, DSC, CE-SDS, cIEF, CD, DLS, Raman, viscometer, and sub-visible particle measurement.
- Ability to work independently in assay development and qualification, with in-depth knowledge of protein stability/degradation.
- A good team player who interacts well with other team members and external partners.
- Strong technical writing and communication skills, with the ability to contribute to the authoring and submission of IND and other regulatory documents.
- Previous experience in process development for biotherapeutics, with knowledge across technical domains, including cell culture, chromatography, and formulation. Working knowledge of CMP compliance.
- Experience in protein/function characterization and LC-MS is preferred.
Who We Are:
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that harness glyco-immunology to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, E-602 (formerly called Sialidase-Fc), is an enzymatic sialoglycan degrader for T cell exhaustion in cancer which is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glyco-immunology plays a role, including inflammatory diseases such as autoimmunity and fibrosis. Palleon was launched in 2015. The company recently raised a $100 million Series B financing from leading investors Matrix Capital Management, Surveyor Capital (a Citadel company), SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures and AbbVie Ventures. Learn more at www.palleonpharma.com.