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About Sonoma Biotherapeutics:

Sonoma Biotherapeutics is a South San Francisco and Seattle-based clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. Sonoma Bio has initiated two Phase 1 studies to evaluate the safety and proof-of-mechanism of the company’s lead Treg cell therapy candidate, SBT-77-7101, in patients with rheumatoid arthritis and hidradenitis suppurativa. The company has a partnership with Regeneron to discover, develop and commercialize novel regulatory T cell therapies. More information at www.sonomabio.com.

Summary

The Associate Scientist opportunity is a lab-based individual contributor role responsible for process development of autologous Treg Cell Therapies. This role reports to the Director of Process Development and will work in close collaboration with scientists across the organization to execute process development, IND-enabling studies, and support tech transfer to CMOs. Proficiency in this role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, a solution-focused mindset, and collaborative skills. This position requires knowledge of aseptic cell culture technique, clinical-stage manufacturing, process characterization, IND- and BLA- enabling study design, and other activities as deemed necessary by program leadership.

Responsibilities:

• Planning, analysis, and execution of studies designed to drive successful process development and process characterization of cell therapies
• Assist in technical transfer from process development to clinical MFG
• Culture human regulatory T-cells (Tregs) in various conditions
• Assist with media preparation and kitting
• Support bulk material generation of cellular products to support internal development organizations

In this role, you will:

• Assist in manufacturing engineered Treg cell products and intermediates in support of process development, analytical development, and process characterization efforts
• Execute experiments with appropriate documentation, data analysis, and drafting of technical reports
• Assist in MSAT activities such as tech transfer to CMO
• Prepare batches of media for cell culture and prepare cytokines for cell culture
• Buffer, cell culture media, and cytokine preparation
• Kitting for manufacturing
• Assist in the development of cell isolation, purification, expansion and formulation protocols and technologies in support of product development from clinical to commercial scale
• Participate in cross-functional collaborations to meet project timelines and material supply requirements
• Assist in the development of standard operating procedures (SOPs), Batch Records and product specifications
• Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity
• Authoring of technical documents critical to process development, process characterization, and tech transfer of cell therapy programs

Qualifications:

• A minimum BS in Biology, Chemical Engineering, Bioengineering or relevant scientific discipline with 5-8 years of industry experience
• Desire and drive to learn about cell therapy process and analytical development
  

Position Requirements:

• Knowledge and experience in designing process development and process characterization studies of cell therapy or biologics manufacturing processes. Understanding of Design of Experiments (DOE) and Quality by Design (QBD)
• Highly organized, detail-oriented individuals with strong problem-solving skills
• Flexibility in working schedule to accommodate weekend work if necessary
• Travel to support tech transfer activities
• Must be able to communicate through excellent verbal and writing skills and multi-task within a fast-paced, highly collaborative team environment with a high degree of self-motivation and organization
• Embodies the company culture of empowerment, diversity, and inclusion
• Ideal candidates will possess experience in:
  • Flow cytometry
  • GMP manufacturing of cell therapy or biological products
  • Process Characterization of cell therapy clinical programs

Physical Considerations:

This position requires the ability to occasionally lift and/or move up to 30 pounds and stand for multiple hours at one time. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. Must be able and willing to gown in an aseptic environment on a regular basis. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment.

Equal Employment Opportunity

At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees.

Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply. Please submit your resume along with a cover letter to careers@sonomabio.com - resumes may also be submitted without applying for a specific job.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us at careers@sonomabio.com