Process Development Specialist I or Associate I/II
Clinical T-Cell Manufacturing (CTCM) | Emeryville, CA | Full Time
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 a strong pipeline 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.
The Process Development Specialist I or Associate I/II will work as part of the Clinical T-Cell Manufacturing (CTCM) group in the Clinical Development team. As an active member of the Clinical Development team, the successful candidate will provide key support manufacturing vector and cell products to enable pipeline programs.
Responsibilities include supporting the implementation and development of successful GMP operations utilizing contract and in-house vector and cell manufacturing facilities.
- Executes studies under supervision to facilitate development of viral vector and/or T cell manufacturing processes
- Participates in routine viral vector and/or T cell manufacturing working closely with Contract Manufacturing Organization and in-house manufacturing team for the technology transfer and troubleshooting of current processes, including travel (10-30%)
- Assists in raw material management and coordinates product shipping logistics
- Planning and hands-on execution of cell-free and cell-based assays (e.g. flow cytometry, cytokine release & killing assay) to characterize viral vector and T cell products, to support process development and early product characterization
- Performs data analysis and reports results to scientific team
- Exercises independent judgment in development of new methods, techniques and evaluation criteria
- Generation of notebooks, protocols
- Other duties as assigned.
- Bachelor's or Master's Degree in Biotechnology, Biochemical Engineering, Chemical Engineering or related discipline with pharmaceutical/biotech manufacturing & process development experience required.
- Minimum of 3 years of pharmaceutical industry or related experiences.
- Hands-on experiences in virology and/or cell biology required with working knowledge of engineering principles.
- Cell culture and aseptic processing experience required.
- Hands-on experience in operating closed system bioprocessing unit preferred (e.g. Xuri/WAVE, CliniMACS, Prodigy, Sefia & Sepax)
- Clear, concise and detail-oriented technical writing.
- Excellent interpersonal, verbal and written communication skills.
- Ability to work in a dynamic environment of a scientifically driven biotech and able to plan and execute simultaneously.
- Ability to evaluate and resolve complex problems under guidance.
For the best fit, the candidate should be a fast learner who is detail-oriented and results-driven with outstanding organizational skills, and a team player with strong interpersonal and communications skills and capable of working collaboratively with colleagues. The candidate should be comfortable in a fast-paced environment, able to adjust workload based upon changing priorities and willing to take additional responsibilities outside of initial job description.
Please submit your resume or CV and cover letter to 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 company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.