Scientist, Cell Culture Development

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Job description

Visterra is a clinical stage biotechnology company committed to developing innova-tive biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases, with an immuno-nephrology focus on drug development. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. We are de-veloping a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 85 employees, and is located in Waltham, Massachusetts.

Summary

The Scientist, Cell Culture Development is a key member of the growing Pharmaceutical Sciences and Technology team, reporting to the head of the cell line and cell culture development team.

The Scientist, Cell Culture Development will be responsible for planning and executing cell culture process development and cell line development in our laboratory. The Scientist will also support contracted cell line development and process development activities at Contract Development and Manufacturing Organizations (CDMOs). The Scientist will oversee technology transfer to manufacturing sites and serve as person in plant during GMP operations. The individual will work closely with internal partners in Quality Assurance, Analytical Development, Research, and Regulatory as well as with external partners.

This is a full-time, lab-based position located at Visterra's offices in Waltham, MA.

Responsibilities

• Conducting shake flask and bioreactor operations for small scale development and characterization of cell culture processes for Visterra's antibody products.
• Conducting cell line development activities in line with regulatory guidance to establish Research Cell Banks for use in GMP Master Cell Bank generation as well as supporting cell line development activities at our contract development organizations.
• Developing producer cell lines from DNA construct assembly through genetic stability testing.
• Developing cell culture platform processes to support in-house material generation to support research and pre-clinical studies.
• Independently operating laboratory cell culture equipment including bench-scale bioreactors, shake flasks, and multiwell plates.
• Monitoring and sampling of cell culture processes daily; including testing for attributes such as cell viability and density, metabolites, pH, and more.
• Participating in and leading cell culture technology transfer activities such as authoring and reviewing process descriptions, reviewing master batch records and process data, and providing on the floor support during GMP manufacturing.
• Presenting work at department and cross functional meetings and contributing as a process lead in drug development team meetings.
• Troubleshooting and maintaining laboratory equipment.
• Documenting experimental results in lab notebooks, tech transfer documents, and technical reports and presenting data at meetings.
• Keeping current with new technologies to improve process development capabilities.

Requirements:

• B.S. in Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or Biological Engineering (or related disciplines) with 4 years of relevant industry experience, or M.S. with 2 years of relevant industry experience or Ph.D.
• Experience in maintaining and troubleshooting mammalian cell culture operations.
• A strong understanding of cell culture parameters in general (cell growth rate, cell density, viability, population doubling, metabolites and cell waste, etc.).
• Experience with standard molecular biology techniques.
• An understanding of cell line development.
• Hands-on experience with aseptic techniques for small scale bioreactor operations.
• Knowledge and experience scaling up processes from bench to commercial manufacturing and supporting technology transfers to CMO.
• Experience with GMP manufacturing operations.
• Experience with transfection of mammalian cells for transient and/or stable expression of genes of interest.
• Experience with Fluorescence Activated Cell Sorting (FACS) of mammalian cells.
• The ability to think critically and communicate effectively across broad spectrum of audiences both internal and external.
• An ability to work independently, meet deadlines and prioritize work effectively.
• The ability to travel to conferences and global manufacturing sites up to 10% of the time.
• Due to the nature of cell culture activities, some work outside of non-standard hours, including weekend work is required.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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BA/BS/Undergraduate