POSITION SUMMARY

Umoja’s Analytical Development organization is seeking a driven Senior Research Associate within the Process Analytics sub team to support in-process and drug substance and product testing of Lentiviral Vector (LVV) . This role will play a key part in routine sample testing, new method development, and method lifecycle management. In addition, they will advance assay execution, data quality, and turnaround time through increased automation by incorporating tools such as AI and Ganymede to support efficient data capture, analysis and decision making.  The successful candidate will have experience performing a variety of molecular, cellular, biophysical, and biochemical protocols. This position works cross-functionally with other departments to test LVV samples as well.

This position plays a critical role in advancing Umoja’s pipeline and Analytical Development capabilities.

This is a full-time onsite lab-based position 5 days/week at our Louisville, CO location.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Assist with method development, execution, analysis, and data review to support the development of gene therapy product
• Perform routine testing (e.g., ELISA, qPCR, ddPCR, flow cytometry) to support process development and stability studies.
• Ability to perform analysis and calculations manually using software such as Excel, JMP, flowjo, prism and R/Python.
• Strong understanding of the automation workflows including analysis platforms (such as Ganymede)and an ability to integrate this tool into multiple analytical methods.
• Maintain clear records of experimental work using an electronic notebook system that adheres to company guidelines.
• Manage sample submissions in Benchling (ELN) for assigned methods and turn around data in timely manner.
• Supports process mapping and identify sources of waste in a workflow and identifies automation opportunities to increase efficiency.
• Exemplifies the company core values and adheres to company policies to ensure safety and quality of gene therapy products, our people, and our facility.
• Collaborate cross functionally with multiple departments like Informatics, Quality Control and Process Sciences.

The successful candidate will have:

• Bachelors Degree in Biology, Biochemistry, or related discipline with at least 2 years of experience or an Associate’s Degree and 4 years of hands-on laboratory experience. Equivalent combinations of education and experience will be considered.
• Hands-on experience with ddPCR, qPCR, ELISA, and/or flow cytometry.
• Detail-oriented mindset with the ability to dig into data analysis and an enthusiasm to take charge on automating assay work-flows and analysis and platform establishment.

Preferred Qualifications:

• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
• Proficient in basic data analysis, and experience developing more complex analyses.
• Self-motivated, organized, and clear documentation.
• 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: $76,300 - $94,300

POSITION SUMMARY

The Vice President of Analytical Development will provide technical, operational, and strategic leadership for Umoja’s analytical development organization, with responsibility for release, characterization, and lifecycle management of analytical methods supporting clinical and commercial cell and gene therapy products. Reporting to the Chief Technical Officer (CTO), this role will define and execute the company’s end-to-end analytical strategy in close partnership with Quality, Manufacturing, Regulatory, and Research.

This individual will be a critical leader at the interface of Research and Discovery, GMP Manufacturing, Quality, and CMC Regulatory, with accountability for analytical method development, qualification, validation, transfer, and specification setting for GMP products. The ideal candidate brings deep regulatory experience—particularly IND and BLA submissions—strong people leadership, and a proven ability to scale analytical organizations in fast-paced biotech environments.

This position is based in Louisville, CO (preferred) or Seattle, WA.

CORE ACCOUNTABILITIES 

Specific requirements include:  

Strategic Leadership & Execution

• Provide strategic leadership and operational oversight for the Analytical Development and Process Analytics teams, including routine testing to support process and product development.
• Define and own Umoja’s overarching analytical strategy across development stages, from early clinical programs through BLA and commercialization.
• Lead the design, implementation, and continuous improvement of laboratory systems and workflows, including development of high-throughput and automated testing strategies.
• Drive organizational change initiatives to continuously improve efficiency, quality, and business outcomes.

Analytical Development & CMC

• Lead analytical method development, process analytics, and lifecycle management for intermediates, drug substance, and drug product testing.
• Establish analytical strategies for specification setting, comparability, and assay robustness consistent with regulatory expectations.
• Provide subject matter expertise to support CMC strategy, regulatory interactions, and responses to agency questions.
• Author and be accountable for analytical sections of regulatory submissions, including INDs and BLAs.

Cross-Functional Leadership

• Build and maintain strong cross-functional partnerships to ensure effective handoffs of technologies, methods, and data across Research, Manufacturing, Quality, and Regulatory.
• Review CMC project plans and timelines; ensure appropriate prioritization and on-time delivery of analytical milestones.

People, Budget & External Partnerships

• Lead strategic planning, annual goal setting, talent development, succession planning, and organizational design for the function.
• Own OPEX and CAPEX planning and execution in collaboration with Finance and HR.
• Ensure the organization meets budgeted financial goals and operates within approved timelines.
• Select, manage, and oversee external contract laboratories and vendors.
• Champion Umoja’s cultural values and foster a high-performance, inclusive, and collaborative team environment.

Leadership Competencies

Setting Strategy

• Articulates a clear, compelling vision for the Analytical Development organization aligned with Umoja’s mission and long-term goals.
• Demonstrates creativity and entrepreneurial thinking to push scientific and operational boundaries.
• Translates strategy into realistic, executable plans with measurable outcomes.

Executing for Results

• Sets ambitious goals and holds self and others accountable for delivery.
• Thrives in ambiguous, rapidly evolving environments and leads effectively through change.
• Acts with integrity, transparency, and sound judgment in decision-making.

Leading Teams

• Builds trust, inspires collaboration, and develops talent across functions and geographies.
• Models resilience, perseverance, and a commitment to excellence.
• Embraces feedback, self-reflection, and continuous improvement.

Relationships & Influence

• Builds strong, authentic relationships through emotional intelligence and clear communication.
• Influences through credibility, passion, and purpose rather than authority alone.
• Celebrates team success and creates a shared sense of meaning and ownership.

The successful candidate will have:

• Advanced degree in Biology, Biochemistry, Chemistry, or a related life sciences discipline (MS or PhD preferred).
• Minimum of 15 years of experience in biopharmaceutical development, with significant leadership experience in analytical development.
• Minimum of 5 years’ experience building, leading, and developing high-performing teams.
• Deep expertise in analytical techniques relevant to cell and gene therapies, including flow cytometry, ELISA, qPCR, ddPCR, and cell-based assays.
• Extensive experience authoring and supporting IND and BLA submissions and engaging with regulatory agencies.

Preferred Qualifications:  

• Strong working knowledge of analytical development, CMC regulatory strategy, and Quality systems in the cell and gene therapy space.
• Demonstrated success scaling organizations and infrastructure in growth-stage biotech companies.
• Strong understanding of ICH guidelines, pharmacopeial standards, and global regulations governing GMP release testing.
• Excellent strategic, operational, financial, and business acumen.
• Ability to manage complexity, prioritize across multiple programs, and influence across a diverse stakeholder landscape.
• A clear vision for building a sustainable, equitable, and values-driven culture across technical functions.

Physical Requirements:  

• Ability to travel up to 20%
• Ability to work onsite at our Louisville, CO (preferred) or Seattle, WA location

Salary Range: $310,000 - $350,000

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 ACCOUNTABILITIES
Specific 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

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