Scientist, Analytical Development

POSITION SUMMARY

Umoja Biopharma is seeking a driven Scientist to 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 position will play a critical role in advancing Umoja’s pipeline and analytical development capabilities.

This role will be onsite 5 days/week based out of our Seattle, WA location.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• 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

The successful candidate will have:

• 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.

Preferred Qualifications:  

• 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

Physical Requirements:  

• Ability to perform standard laboratory tasks with appropriate PPE

• Perform physical tasks required to support laboratory work, including standing, walking, bending, kneeling, sitting, working with your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds
• Ability to spend prolonged periods of time working on a computer
• Ability to work onsite 5 days/week

Salary Range: $122,000 - $150,800