Job Description
Job DescriptionSalary: $95,000 - $126,000
TheSenior Research Associateis a key member of thegrowingPharmaceutical Sciences and Technologyteam andis responsible forexecuting cell culture development activities in our laboratory and contributing toprojects with ourpartner organizations.
Reportingto the Senior Process Scientist (the leader of the cell culture team),theSenior Research Associaterole willexecute cell line development workflows andcell culture development experiments inourlaboratory. TheSenior Research Associate willalso contribute tocontracted activities atContract Development and Manufacturing Organizations (CDMOs).The individual will work closely with internal partners in Quality Assurance, Research, and Regulatory as well as with external partners.
Responsibilities
- Conducting shake flask and bioreactor operations for small scale development and characterization of cell culture processes forVisterrasantibody products.
- Conducting cell line development activities in line with regulatory guidance toestablishResearch Cell Banks for use in GMP Master Cell Bank generation.
- Assistwith developing producer cell lines from DNA construct assembly through genetic stability testing.
- Independentlyprepare DNA vectorsusing standard molecular biology techniquesincluding homology-based cloning, transformation and propagation in bacteria, andkit-based purification.
- Independently execute work todevelop 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, andmultiwellplates.
- Monitoring and sampling of cell culture processes daily; including testing for attributes such as cell viability and density, metabolites, pH, and more.
- Contribute to cell culture technology transfer activitiesincluding:
- reviewing and presenting process data
- troubleshooting results of small scale and pilot scale data
- performing scaleup calculations
- Support GMP manufacturing throughreview ofBatch Records and support for deviation investigations
- Support GMP manufacturing as a Person-in-PlantrepresentingVisterra atCDMO sites.
- Presenting work at department and cross functional meetings and presenting relevant updates on lab activities at drug development team meetings.
- Troubleshooting andmaintaininglaboratory equipment.
- Documenting experimental results in lab notebooks, tech transfer documents, and technical reports and presenting data at meetings.
- Keepingcurrent withnew technologiesto improve process development capabilities.
- Traveling up to 10%of the timefor site visits at CDMOs and to attend conferences
Requirements
- B.S. in Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or Biological Engineering (or related disciplines) with3years of relevant industry experience,orM.S. with1years of relevant industry experience
- Experience inmaintainingand troubleshooting mammalian cell culture operations.
- A strong understanding of cell culture parameters in general (cell growth rate, cell density, viability, population doubling,metabolitesand cell waste, etc.).
- Hands-on experience with aseptic techniques for mammalian cell culture operations.
- Experience withtransfection of mammalian cells for transient and/or stable expression of genes of interest.
- The ability to think critically and communicate effectively acrossbroadspectrum 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 weekendworkis required.
Company
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney, immune-mediated and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs. Visterras pipeline has multiple clinical-stage assets and one approved therapeutic, sibeprenlimab.
As a member of the Otsuka family of companies, we are uniquely positioned as a small, dynamic, nimble and innovative organization where individuals and teams are empowered to make big impacts while benefiting from the support, strength, stability and long-term perspective of a 100-year-old global company. Visterra has approximately 105 employees and is located in Waltham, Massachusetts.
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.