Scientist, Analytical Development
About The Position
Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Their vision is to develop off-the-shelf therapies capable of treating any tumor, any time. The company is a diverse and growing team working in brand-new facilities and is looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. The Scientist, Analytical Development will understand and assess the potency of lentiviral drug products. This role will develop early- and late-stage potency methods for release of drug substance/product and generate data packages to support regulatory submissions. The position will work closely with other functions to deliver qualified/validated QC release and characterization assays, generate associated documentation, and oversee transfer of methods internally or externally to a CMO/CRO. As a laboratory-based position within the technical operations organization, this role will play a critical part in advancing Umoja’s pipeline and analytical development capabilities. This role will be onsite 5 days/week based out of the Seattle, WA location.
Requirements
- PhD/MS/BS in Immunology, Cellular Biology, Molecular Biology or related discipline with at least 0+/8+/10+ years of experience, respectively; equivalent combination of education and experience will be considered
- Proven track record in cell-based method development, including troubleshooting assays, experimental design, execution, and evaluation of data
- Ability to work in a fast-paced environment with broad responsibilities, meet deadlines, and prioritize work on multiple projects
- Strong communication skills in technical writing and oral presentation.
- Respectful of others and open to new ideas.
Nice To Haves
- Hands-on experience with multicolor flow cytometry, cell-based assays, ELISAs, viral transduction, and qPCR/dPCR
- Experience qualifying and transferring analytical methods to a QC lab or CMO/CRO
- Experience developing and qualifying potency methods according to ICH/USP guidelines and authoring method documentation
Responsibilities
- Successful design, execution, analysis, and documentation of experiments to develop analytical methods and key data packages for lentiviral gene therapies.
- Perform experiments to support analytical development and product characterization using advanced techniques including multicolor flow cytometry, ELISAs, Western blots, qPCR/dPCR, signal transduction and cytokine assays.
- Oversee the qualification of analytical methods.
- Author, review and approve technical documents including electronic notebook entries, standard operating procedures, test methods, technical reports, etc.
- Present findings on method development and communicate interpretation and strategic plans related to the potency of our drug product to cross-functional teams.
- Foster good teamwork and communication.
- Build a reputation of excellence as an individual and as a team.
- Collaborate with stakeholders within Analytical Development (Product Sciences and Process Analytics teams) and cross-functionally with Quality Control, CMC, Translational Medicine, Process Sciences, Discovery, and Vector Biology
- All other duties as assigned
Benefits
- competitive Medical, Dental, and Vision plans
- access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral
- generous Paid Time Off policy
- employee commuter benefits
- cell phone stipend
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
