Vice President, Analytical Development

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