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Industry: Zeitungsverlage
Company Size: 201–500 Beschäftigte

CHEManager International

Savvy Admin PROD

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's Analytical Development organization is seeking a driven Scientist to deliver routine (U)HPLC as well as troubleshoot, improve and/or develop separations based analytical methods for the Process Analytics department. This role will be responsible for managing current method lifecycle and developing new separation strategies to quantify residual process reagents, impurities in lentiviral vector (VivoVec) Drug Product and assist in product and process characterization. This position requires an exploratory and proactive approach to method development, including identifying and developing new separation methods to quantify residuals in VivoVec, raw materials, and media components to support evolving process needs, using appropriate chromatographic and detection strategies.

The ideal candidate is experienced in chromatography systems and multiple detection methods and will work independently to meet timelines. Responsibilities may include oversight and transfer of analytical assays for internal and external partners, qualification of newly developed or external methods, and successful transfer of methods to QC to enable release of GMP material. This role balances routine sample testing to support ongoing process needs with development, qualification, and transfer activities, and requires strong communication skills to collaborate with cross-functional and external partners. Attention to detail, thorough documentation of experimental work in an Electronic Laboratory Notebook (ELN), and authorship of development and qualification reports are essential.

This role is fully onsite and lab-based 5 days/week at our Louisville, CO location.

**CORE ACCOUNTABILITIESSpecific Responsibilities Include**

- Develop and execute novel (U)HPLC and separation methods to characterize and quantify lentiviral products, raw materials and impurities, including process reagents, to demonstrate effective clearance

- Collaborate with AD and QC team members on various stages of analytical method lifecycle (development/qualification/transfer)

- Collaborate with informatics engineers to create sample submission/result reporting workflows and integrate automation to support ongoing testing and improve efficiency.

- Maintain clear records of experimental work using an electronic notebook system that adheres to company guidelines.

- Manage and prioritize sample submissions for respective method(s) and report data in timely manner

- Prepare technical data reports and presentations

- Contribute to other analytical method(s) development and testing as necessary

- Exemplify the company core values and adhere to company policies to ensure safety and quality of gene therapy products and facility.

**The Successful Candidate Will Have**

- PhD/MS/BS in Biology, Biochemistry, or related discipline with of relevant experience, respectively. Equivalent combination of education and experience will be considered.

- Expertise with (U)HPLC systems and chromatography separation analytics, Thermo (Chromeleon) preferred with multiple separation and detection methods

- Experience in novel method development and method improvement initiatives

- Excellent communication skills with the proven ability to build open and collaborative relationships and successfully work as a member of a multidisciplinary team

**Preferred Qualifications**

- Expertise with nano and (U)HPLC

- Experience with UV/VIS, Fluorescence, CAD, quadrupole MS, ICP-MS detection

- Experience with viral vectors (e.g., AAV, LVV) and/or additional analytical methods (dPCR, qPCR, ELISA, etc.) a plus

- Experience in method qualification and Quality transfer

- Self-motivated and organized

- Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects

**Physical Requirements**

- 100% compliance with personal protective equipment (PPE) requirements in laboratory environments, including gloves, protective clothing, and eye safety glasses.

- Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.

- Ability to work onsite 5 days/week at our Louisville, CO location.

**Salary Range: $122,100 - $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.

Scientist, Analytical Development

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