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Vector Process/Analytical Development/Ctcm Scientist

Eureka Therapeutics

Vector Process/Analytical Development/Ctcm Scientist

Emeryville, CA
Full Time
Paid
  • Responsibilities

    Vector Process/Analytical Development/CTCM Scientist Clinical Development | Emeryville, CA | Full Time Job Description About Us: Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR- mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com. Job Description: Eureka Therapeutics Inc. is looking for a Vector and T Cell Manufacturing Process Development scientist with primary focus on vector manufacturing process and assay development, with secondary focus on T cell process development. As a CTCM Scientist, the candidate will contribute as a key member of the Eureka Clinical Development team to develop and optimize vector production process while supporting clinical T cell manufacturing (CTCM) activities across the Companys product pipeline programs of novel autologous T cell therapies. This position will be a member of clinical team and reporting to the Chief Medical Officer (CMO) and will be responsible to support implementation and development of successful GMP operations utilizing contract and future in-house vector and cell manufacturing facilities, other vendors, as well as internal resources. Eureka is a high growth, fast paced, small organization. The ability to be productive and successful in an intense work environment is critical. Activities: Assist in creating process and assay development programs for manufacturing of viral vector products, in addition to assisting project and material forecasts. Hands-on cell culture activities across a variety of bioreactor platforms (stirred tank, rocker and cell factory) and scales. Cell culture process development, focusing on screening and optimization of upstream bioreactor process for early phase vector production, with the goal of scalable process for late phase applications. Hands-on purification development experience including screening, optimization, and scale-up of chromatography and filtration processes including ion-exchange chromatography, depth filtration, tangential flow filtration and sterile filtration. Scale-down model development and implementation of upstream cell culture and downstream purification technology Serve as subject matter expert for routine manufacturing of viral vectors, working closely with the technology transfer and CMO or future in-house manufacturing teams to troubleshoot processes in manufacturing. Improve process performance and efficiencies across early and late stages of development and clinical/commercial manufacturing with in-house manufacturing or CMO. Support and drive process development and process characterization, ranging from design to execution of laboratory studies, leading to a thorough understanding of operating and performance parameters, to support materials or process changes. Development and execution of analytical (e.g. virus titering assays) and other laboratory studies to support process development, in-process and release testing, and characterization for viral vector production. Review and generation of notebook, protocol and technical documentations. Technology transfer to GMP manufacturing facilities, including possible travel (20-30%) to support facilities located outside Emeryville, CA. Other duties as assigned. Requirements: Masters or PhD Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, or related discipline with pharmaceutical/biotech manufacturing & process development experience required. Minimum of 2 years of pharmaceutical industry experience. Expertise with cGMP manufacturing and regulatory regulations and requirements for biologics under CBER. Hands-on experiences in virology and/or cell biology required with working knowledge of engineering principles. Cell culture and aseptic processing experience primarily focusing on the benchtop systems, with large scale single use bioreactor experience, a plus. T cell development and manufacturing skills are a plus to support T cell processing as needed. Clear, concise, and detail-oriented technical writing. Excellent interpersonal, verbal and written communication skills. Ability to work in a dynamic, scientifically-driven biotech environment, with limited resources; Ability to plan and execute simultaneously, as well as to evaluate and resolve complex problems. For the best fit, the candidate should be a fast learner, results-oriented, has outstanding organizational skills, be a team player with strong interpersonal and communications skills, and work collaboratively with colleagues. Comfortable in a fast-paced environment and able to adjust workload depending on changing priorities and willing to take on additional responsibilities outside of initial job description. To Apply: If you are interested in applying to our open positions, please submit your resume and cover letter via JobScore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year. Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law. If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your companys gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.

  • Industry
    Biotechnology