San Francisco, CA
The Process Development Scientist will lead the continued optimization of Amunix’s established purification processes, initiate project-specific purification development strategies, and perform purification operations. This position heavily supports Amunix’s R&D efforts, and it interfaces internally with Molecular Biology, Fermentation Operations, and Analytical Chemistry as well as externally with partners both domestic and abroad. Initiative, ingenuity, flexibility, and communication are paramount in this role.Responsibilities:
-Develop and optimize processes for recovery, clarification, chromatography, and formulation
-Serve as the protein purification process development subject matter expert in the project team.
-Develop processes and generate documents including batch records, summary, and technical reports.
-Design and execute experiments, collect and analyze data. Present process analysis, trending and summary to the group in a timely manner.
-Generate, enhance, and enrich process understanding knowledge. -Design and execute strategies for process and product impurity clearance
-Initiate novel process / technology when applicable.
-Collaborate with other teams and CDMO partners in designing manufacturing processes and assist with tech transfer activities
-Design strategies and perform experiments to increase primary recovery of Amunix proteins
-Lead, train, and coach junior staff
-Troubleshoot problems with process and equipment and propose solutions
-Design and execute experiments focused on robustness, scalability, titer, and quality
-Self-motivated, ability to work independently and within a cross-functional team
-Contribute to relevant sections of IND filings and other documentation -Communicate effectively and in a timely fashion
-Routinely update a cross-functional team on experimental plans and outcomes
-Work with vendors to maintain production equipment
-Ph.D. in Biology, Chemistry, Biochemistry, or similar
-5 years of work experience in process development in a biopharmaceutical company
-Expertise in Recovery, Chromatography, Formulation, Sterile & Aseptic processing is required
-Experience with scale-up and transfer of a process from bench-scale to pilot-scale to commercial scale
-Significant experience developing and troubleshooting protein purification processes is required.
-The successful candidate will be proficient in all unit operations and related software of DSP including chromatography, dead-end filtration, and tangential filtration instruments
-DSP related process analytics experience in process performance, protein quality, and residuals required
-Knowledge/ experience in working with recombinant proteins or antibodies from multiple platforms (E. coli, CHO). Desire and curiosity to develop a novel class of therapeutic proteins are highly preferred
-Experience in design of experiments strongly preferred. Experience with statistical software and process validation activities desired
-Experience with purification and handling of metastable proteins
-Experience with AKTA Avant or Pure preferred
-Experience with protein conjugation chemistry is desirable