Senior Bioprocess Development Scientist - Protein Production

About the role

The Microbiome Therapies Initiative (MITI) at Sarafan ChEM-H is seeking a highly motivated protein scientist for a role in our ambitious new effort to develop and produce commensal vaccines in-house at Stanford for clinical use. At MITI, we aim to take advantage of the tremendous promise of the microbiome to treat human disease. In this position, you will be MITI’s primary expert on protein expression and purification, reporting to the Associate Director/GMP Supervisor. You will lead the development, execution, and troubleshooting of an array of protein production strategies needed to support the success of the commensal vaccine platform. You will adapt these strategies for the GMP production of MITI’s clinical products, participating in the redesign of our GMP suite for vaccine production and in the in-house manufacturing, formulation, and release process itself. Your colleagues will be MITI’s GMP manufacturing, quality, and regulatory team members. You will collaborate with members of the Fischbach lab at Stanford who have created this novel vaccination strategy. Ideal candidates are self-starters, comfortable with autonomy, yet embrace opportunities to tackle new problems and challenges as part of a dynamic team in a start-up-like environment within the University.

Sarafan ChEM-H is a new interdisciplinary institute focused on connecting Chemistry, Engineering, and Medicine for Human Health. The institute was founded as a joint venture of the Schools of Medicine, Engineering, and Humanities and Sciences. The proximity of world-class biologists, chemists, engineers, and clinicians at Stanford presents a unique opportunity to study human biology at a molecular level, to translate this knowledge into groundbreaking products and services that promote healthy living, and to educate a new cadre of “physician-scientist-engineers” who will lead a rapidly evolving industry. The institute’s Knowledge Centers serve as shared laboratories where trainees from diverse disciplines in science, engineering and medicine pursue projects under the mentorship of the center’s Directors, thereby gaining hands-on skills in high-throughput screening, medicinal chemistry, metabolomics, protein chemistry, and structural biology.

Responsibilities

• Design, coordinate, execute, and troubleshoot protein expression and production processes across multiple projects
• Work with the Associate Director to scale/adapt existing production processes for in-house GMP production
• Perform GMP pilot and production runs as part of MITI’s manufacturing team
• Author relevant SOPs, work instructions, and batch records, and participate in GMP trainings, document control, and CAPA processes
• Contribute to CMC sections of Investigational New Drug (IND) applications
• Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements
• Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager
• Develop methods for, perform and supervise manufacturing of clinical materials according to cGMP standards in Biosafety