Scientist, Analytical Development

Job Description

Job Description

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. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are 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. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

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

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.