Process Development Scientist I
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 Scientist I will work as part of the Clinical T-Cell Manufacturing (CTCM) group in the Clinical Development team. As a key member of the Clinical Development team, the successful candidate will contribute to the development of Eureka’s vector and T-cell manufacturing processes. In addition, he/she will provide key support to other activities across the Company’s product pipeline programs.
Responsibilities include supporting the implementation and development of successful GMP operations utilizing contract and in-house vector and cell manufacturing facilities as well as internal resources and other vendors.
- Contributes independently to the development of viral vector and/or T cell manufacturing processes
- Independently designs, plans and executes studies to support the optimization of the viral vector and/or T-cell manufacturing process and to enable clinical trials
- Participates in and leads 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 day travel to another site (10-30%)
- Supports and drives process characterizations, ranging from the design, management and execution of the laboratory studies (in house and with vendors), in order to achieve a thorough understanding of operation and performance parameters
- Development and hands-on execution of cell-free and multiplexed 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
- Exercises independent judgment in development of new methods, techniques, and evaluation criteria
- Drafts, reviews and amends standard operating procedures (SOPs) for manufacturing process and product characterization
- Generation of notebooks, protocols and other technical documentation
- Other duties as assigned
- Ph.D Degree in Biotechnology, Biochemical Engineering, Cell Biology or related discipline with pharmaceutical/biotech manufacturing & process development experience preferred.
- Minimum of 2 years of related experiences; experience in bioengineering is highly preferred.
- Working knowledge with cGMP manufacturing and regulatory requirements for biological products.
- Hands-on experiences in virology and/or T-cell biology required with working knowledge of engineering principles.
- Cell culture and aseptic processing experience required.
- Hands-on experiences 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.
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.