POSITION SUMMARY

Umoja Biopharma is looking for a Senior Analyst, Quality Control Microbiology to perform testing and monitoring activities in support of the QC Microbiology laboratory and manufacturing areas at Umoja’s lentiviral vector manufacturing facility.

This role reports to the Senior Manager, Quality Control Microbiology and will be based fully onsite in Louisville, CO.

REQUIREMENTS 

Specific responsibilities include:  

• Performs and reviews routine Quality Control laboratory work, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, microbial identification, raw material sampling and inspection, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing
• Generates and revises Quality Control documents according to established document management processes
• Assists in the development of training materials and independently delivers training to staff for QC programs, systems, and processes
• With management oversight, executes qualification/validation activities for QC laboratory equipment, instruments, and systems
• With management oversight, executes internal and external method establishment (e.g., qualify, validate, verify, transfer) protocols to ensure QC readiness for production activities
• Initiates and supports microbial excursion investigations related to facility and personnel monitoring programs (e.g., environmental monitoring, aseptic gowning, utility monitoring, etc.) through collaboration with other functions (Engineering, Manufacturing, MSAT, etc.)
• Applies and advances Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems
• Prepares, ships, and tracks samples to outside testing laboratories
• Demonstrates the Umoja values as part of a high-performing, people-focused, inclusive, and collaborative organization
• Performs additional duties within the Quality organization, as required

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with 3-5 years of experience working in a cGMP regulated QC environment. Equivalent combinations of education and experience will be considered.
• A passion for teamwork and unwavering commitment to purpose, team success, and contribution to an outstanding workplace culture
• An understanding of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment

Preferred Qualifications:  

• Quality Control experience in an FDA-regulated industry supporting cGMP manufacturing areas
• Previous experience working in a clean room environment
• Previous experience working in cGMP cell and gene therapy manufacturing and/or testing facility
• Previous experience implementing a Laboratory Information Management System along with associated processes and documents

Physical Requirements:  

• Ability to work on-site 5 days/week at Umoja’s manufacturing facility in Louisville, CO
• Ability to aseptically gown and work while standing for extended periods of time
• Ability to regularly lift 20 lbs. and periodically lift up to 50 lbs.

 Senior Analyst, Quality Control Microbiology Salary Range: $71,000 - $87,800

Specialist, Quality Control Microbiology Salary Range: $92,900- $97,545

POSITION SUMMARY

The Associate Director, Statistical Programming will be responsible for strategic planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance. This role will operate as an individual contributor and is responsible for enhancing the statistical programming infrastructure of the Biometric department, building and leading a highly efficient data and matrixed statistical programming team (contractors, vendors, CROs, FTEs) over time.

This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and successful regulatory interactions.

This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Lead statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle.
• Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality.
• Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.)  adheres to regulatory requirements and is compliant with CDISC standards.
• Lead and support statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
• Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
• Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
• Mentor and provide technical oversight to statistical and data programmers and contractors.
• Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
• Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
• Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for statistical programming and data traceability.

The successful candidate will have:

• MS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and statistical programming proficiency with a minimum of 10 years of experience in pharmaceutical companies or CROs is required.
• At least 5 years of demonstrated leadership experience in projects and managing, mentoring, and developing teams.
• A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
• Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge.
• Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers.
• A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Preferred Qualifications:  

• Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials.
• Experience in immunology, hematology, or oncology clinical trials is preferred
• Experience with using R in clinical analysis

Physical Requirements:  

• Ability to sit for prolonged periods of time
• Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material
• This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week
• If this role is remote, the ability to travel up to 20% as needed

Salary Range: $185,100 - $228,700

POSITION SUMMARY

Umoja Biopharma is seeking a Senior Manager, Quality Assurance (QA) Operations to support GMP operations at Umoja’s state-of-the-art lentiviral vector development and manufacturing facility, The CLIMB, in Louisville, CO. This position delivers leadership and management oversight of the QA Operations team, which provides QA partnership and oversight of all GxP functions (e.g., Manufacturing, Supply Chain, Facilities, Engineering, etc.)  at The CLIMB.

This role is fully onsite at our Louisville, CO location 5 days/week. This role may require weekend, evening, or holiday work when necessary.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Exemplifying, role modeling, and maturing Umoja’s quality culture
• Managing, building, and maturing a high-performing, solution-oriented function that nurtures strong cross-functional working relationships
• Leading, managing, and supporting QA Operations to provide QA partnership and oversight (e.g., controlled documents, change controls, deviations, CAPAs, work orders, etc.) of GxP functions (e.g., Manufacturing, Supply Chain, Facilities, Engineering, etc.) at The CLIMB
• Supports QA Operations teams collaborative interactions with cross-functional partners in translating applicable laws, regulations, and guidance (e.g., FDA, ICH, EMA, etc.) into compliant & efficient internal procedures and ways of working in accordance with phase-appropriate cGMPs and effective quality risk management principles
• Engaging with key stakeholders and utilizing Operational Excellence principles and tools to drive continual improvement of the Umoja Quality Management System
• Championing Umoja QA’s “purposeful presence” initiative, ensuring productive and intentional QA partnership with cross-functional teams
• Overseeing disposition of product and incoming materials
• Advancing Umoja’s Quality Risk Management (QRM) program and associated processes
• Partnering with senior Quality management to develop a QA Operations functional strategy to achieve short-term and long-term organizational and company goals & objectives
• Translating functional area strategy into an efficient tactical execution plan that prioritizes functional workload
• Establishing, monitoring, and maturing key business performance metrics to facilitate continual improvement opportunity identification and execution.
• Developing and maintaining capacity and resource modeling tools for the QA Operations functions
• Development of QA Operations team through engaging, purposeful development planning and routine follow-up
• Representing QA Operations on cross-functional leadership and project teams
• Supporting the preparation of documents and sections for regulatory dossiers (e.g., briefing books, IND sections, BLA sections, etc.)
• Providing support for audits and inspections, where needed
• Providing additional Quality Assurance support and leadership, as needed

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 10+ years of work experience in an FDA regulated industry.
• Minimum of 4+ years of successful people management experience with demonstrated ability to build, develop, and lead a high-performing team.
• Advanced knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment across different phases of product development
• Strong understanding of foundational Quality systems (e.g., audits/inspections, documentation, NC/CAPA, Quality Risk Management, etc.)
• Previous experience releasing product for clinical and/or commercial use
• Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic GMP environment
• Ability to think and lead conceptually, strategically, and tactically, arriving at practical and pragmatic conclusions
• Ability to translate complex processes and competing priorities into a clear, actionable plan for execution
• Experience in cGMP cell and gene therapy manufacturing facility

Preferred Qualifications:  

• Previous experience with audits and health authority inspections
• Previous experience providing QA oversight of sterile injectable product(s)

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment
• Ability to work while gowned for extended periods of time
• Ability to stand for extended periods of time to fulfill on-the-floor Quality duties
• Use of laboratory equipment includes handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work occasional evenings, holidays, and weekends as needed

Salary Range: $155,000 - $191,500

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

Umoja Biopharma is seeking a Senior Manager, Quality Assurance (QA) Operations to support GMP operations at Umoja’s state-of-the-art lentiviral vector development and manufacturing facility, The CLIMB, in Louisville, CO. This position delivers leadership and management oversight of the QA Operations team, which provides QA partnership and oversight of all GxP functions (e.g., Manufacturing, Supply Chain, Facilities, Engineering, etc.)  at The CLIMB.

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

CORE ACCOUNTABILITIES

Specific responsibilities include: 

• Model Umoja values by setting clear expectations, coaching performance, and building an inclusive, high-accountability culture within QC Analytical.
• Own day-to-day QC Analytical lab operations (planning, staffing, scheduling, and execution) across analytical testing, stability programs, and sample management to ensure compliant, on-time delivery of testing results in support of corporate goals and program milestones.
• Lead a matrixed team of full time employees and contractors, including recruiting, performance management, and talent development
• Oversee use and continuous improvement of QC Analytical programs, processes, and systems to ensure consistent cGMP execution and scalability.
• Drive implementation and adoption of lab digital and automation tools (e.g., LIMS, reagent management, electronic lab notebook) to improve throughput, right-first-time performance, and compliance.
• As QC Analytical management, collaborate with Analytical Development to ensure method readiness for QC (transfer, qualification/validation, training, and routine execution) in support of analytical method lifecycle activities.
• Forecast demand and build capacity plans (headcount, training, equipment, and coverage) aligned to manufacturing timelines and program needs.
• Champion Operational Excellence/Lean by establishing metrics, standard work, and continuous improvement initiatives that measurably improve quality, cycle time, and efficiency.

The successful candidate will have:

• Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or related life science, plus 8+ years of experience in cGMP Quality Control. Equivalent combinations of advanced education and experience will be considered. Extensive knowledge of analytical method qualification, validation, and transfer.
• 4+ years of demonstrated people leadership experience in a cGMP environment—hiring, coaching, developing, and retaining talent while setting clear priorities and driving accountability.
• Deep hands-on and applied knowledge of molecular biology analytical techniques (e.g., PCR, ELISA, flow cytometry, cell-based assays)
• Working knowledge of applicable regulations and compendial/industry guidance (e.g., ICH, USP) with the ability to translate requirements into practical, inspection-ready QC practices.
• Experience leading teams with direct reports, including performance management, talent development, and building a culture of quality, collaboration, and continuous improvement.
• Proven Operational Excellence/Continuous Improvement capability, applying Lean principles and data-driven problem solving to improve quality, throughput, and right-first-time performance.
• Strong judgment and risk-based decision-making—able to propose solutions, communicate risks, and anticipate downstream impact in a fast-paced, evolving environment.
• Track record of raising team performance through clear expectations, effective communication, strong follow-through, and consistent accountability.
• Proven ability to lead cross-functionally and deliver results by aligning stakeholders, removing roadblocks, and communicating progress, risks, and decisions.

Preferred Qualifications: 

• Experience building and scaling an early phase QC laboratory, including quality systems and analytical method lifecycle ownership (transfer, qualification, validation, and method performance).
• Cell and gene therapy experience in a cGMP setting, specifically QC testing in support of lot release/stability and successful cross-functional partnerships with Technical Operations, Analytical Development and Quality.
• Experience leading through audits/inspections (internal, client, or regulatory) and driving inspection readiness.
• Experience implementing and optimizing LIMS/data integrity controls and digital transformation at scale.
• Experience owning or partnering on deviations/investigations, CAPA, and change control for QC labs.

Physical Requirements:  

• Ability to work onsite 5 days/week at our Louisville, CO location
• Ability to work evenings and/or weekends as needed
• Ability to gown aseptically and work in a Clean Room environment
• Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
• Ability to work while gowned for extended periods of time
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs.

Salary Range:  $152,700 - $188,700

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 Biopharma is seeking a Quality Assurance Specialist to support GMP operations at Umoja’s state-of-the-art lentiviral vector development and GMP manufacturing and testing facility, The CLIMB, in Louisville, CO. This position will provide quality oversight of incoming materials, manufacturing, and general QA support of GMP operations at The CLIMB.

This role is fully onsite based out of our Louisville, CO location.

CORE ACCOUNTABILITIES
Specific responsibilities include:  

• Exemplify and role model Umoja’s quality culture
• Build strong, effective, and productive cross-functional working relationships
• Interfaces with other departments (e.g., Manufacturing, Supply Chain, Quality Control, Facilities, Engineering) to ensure compliance with all applicable procedures, policies, regulations, and standards.
• Provides QA “on the floor” support to Manufacturing during routine GMP operations at the site and Warehouse for material support and disposition.
• Reviews and approves work instructions, Standard Operating Procedures (SOPs), Material specifications, and other controlled documents related to GMP operations and other cGMP activities as needed
• Performs disposition of incoming GMP materials  
• Initiates Quality Holds as required
• Provides oversite on new material introductions including review and approval of new GMP material onboarding requests
• Partners with Manufacturing to review and post-approve GMP executed batch records and protocols
• Reviews and approves Master Batch Records, process SOPs, and supporting forms for products
• Supports line clearance/product changeover activities including the review and approval of associated documentation
• Approves work orders within Blue Mountain Regulatory Asset Manager (BMRAM), as needed
• Review and approves QC documentation (e.g., stability protocols) 
• Provides Quality support to approve, review and close quality records (e.g., Change Controls, Deviations, and CAPAs, etc.) as necessary
•  Identify, propose, and actively participate in opportunities for continuous improvement
• Provides additional support within the Quality organization, as needed

The successful candidate will have:

• Bachelor’s degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 5 years of work experience in an FDA regulated industry
• Previous experience in a Quality organization supporting cGMP biopharmaceutical internal manufacturing facility operations
• Knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment
• An understanding of foundational Quality systems (e.g., Good Documentation Practices, data integrity, audits/inspections, Change Control, Deviation/CAPA, etc.)
• Risk-based and practical decision-making capability, with an understanding on when decision making escalation is required
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas

Preferred Qualifications:  

• Experience in cGMP cell and gene therapy manufacturing facility

Physical Requirements:  

• Ability to work onsite 5 days/week at our Louisville, CO location
• Ability to lift up to 20 lbs. on occasion
• Ability to stand for extended periods of time
• Adherence to proper personal protective equipment (PPE) when necessary, such as but not limited to high-visibility safety vest, cold gloves, lab coat, safety glasses, gowning for manufacturing (scrubs, coveralls, hair net, beard net, etc), etc.
• Ability to support off-hours work on evenings, holidays, and/or weekends when necessary

Salary Range: $85,300 - $105,300

POSITION SUMMARY

Umoja is seeking a skilled Senior Enterprise Systems Analyst to support and enhance our portfolio of enterprise applications. This role serves as a subject‑matter expert across systems supporting Supply Chain, Finance, Accounting, Procurement, HR, and Quality. You will manage day‑to‑day system operations, troubleshoot issues, and lead the delivery of new capabilities. In partnership with cross‑functional teams, you will translate business needs into technical solutions, drive process improvements, support projects from design through implementation, and ensure regulatory compliance in a fast‑paced biotech environment. While NetSuite is the primary system of ownership, this role will also administer and support additional enterprise applications across the organization.

This role is based in our Louisville, CO site and is expected to work onsite at least 3 days/week.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Develop, test, implement, and support enterprise systems to ensure reliable business operations.
• Administer and optimize the NetSuite ERP platform, including configuration, master data, reporting, integrations, and issue resolution.
• Provide hands‑on application support to troubleshoot and quickly resolve system issues.
• Collaborate with internal teams and external vendor partners to maintain and enhance enterprise applications.
• Support planning, design, and rollout of new capabilities, ensuring strong adoption and change readiness.
• Partner with IT to monitor, troubleshoot, and enhance integrations across enterprise systems.
• Ensure systems comply with SOX, SEC, and FDA 21 CFR Part 11 requirements and support audit activities.
• Support validated system lifecycle activities including release management, change control, testing, user access reviews, and periodic audit readiness.
• Gather business requirements and contribute to IT roadmaps, translating needs into actionable initiatives.
• Develop documentation, deliver user training, and support organizational change management.

The successful candidate will have:

• Bachelor’s degree or higher in Information Systems, Business Administration, or related field and 5-8 years of professional experience.
• 5+ years of hands‑on NetSuite administration experience, with a strong focus on Supply Chain, Inventory, WMS, and Procurement.
• Proficiency with NetSuite workflows, saved searches, and SuiteScript.
• Experience supporting core SCM functions: item management, demand planning, purchasing, inventory, and WMS.
• Hands on experience with SOX, FDA 21 CFR Part 11, ISPE GAMP 5, compliance frameworks.
• Experience administering or supporting other enterprise SaaS applications (HRIS, Quality, Budget, P2P, etc.)
• Ability to troubleshoot system issues, manage integrations, and support end‑users across operational teams.

Preferred Qualifications:  

• Strong understanding of NetSuite SCM, Inventory, WMS, Finance, Procurement, and Manufacturing modules.
• Experience in manufacturing environments and familiarity with production workflows, BOMs, routings, quality, and MRP.
• Experience with cloud-based enterprise applications: Coupa (Procure‑to‑Pay or Invoice‑to‑Pay); FloQast; Veeva; UKG or similar solutions.
• Strong business process analysis and system design skills.
• Excellent relationship‑building skills and a collaborative, positive mindset.
• Experience in biotech, life sciences, manufacturing, or other regulated industries.
• Familiarity with integration platforms such as Celigo or Boomi.
• Strong understanding of procurement best practices, supplier management, and supply chain operations.
• A positive, proactive, and service-oriented approach, with a commitment to continuous learning and improvement.

Physical Requirements:  

• Ability to sit for prolonged periods of time
• Ability to work onsite in Louisville, CO at least 3 days/week

Salary Range: $116,800 - $144,300

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

The Senior Clinical Trial Manager is primarily responsible for the operational management and oversight of Umoja’s clinical studies. This individual will work closely with Clinical Operations leadership, Medical Director(s), other cross-functional team members, and designated CROs to ensure the successful completion of all clinical study activities and project deliverables within specified quality, time, and cost parameters.

The ideal candidate brings clinical operations expertise in biotech and the ability to thrive in a fast-paced, entrepreneurial environment.

This role is ideally based out of our Seattle, WA location and is onsite at least 2 days/week. We are open to remote work within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently develop study timelines, key deliverables, and risk/mitigation strategies
• Lead selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• Plan and lead study team meetings
• Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets)
• Contribute to the content and review of study documents (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, product administration guidelines)
• Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and trial closeout
• Ensure accurate and timely execution of site visit monitoring reports
• Identify, select, and monitor performance of sites
• Negotiate and manage the budgets and payments for sites
• Develop and maintain strong working relationships with study investigators and site staff
• Manage investigational product release packages and investigational product accountability
• Coordinate with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Oversee the Trial Master File according to ICH- GCP and SOPs
• May assist in clinical data review and query generation
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Actively participate in and contribute to the development of department initiatives aimed at improving efficiency and best practices

The successful candidate will have:

• Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 6 years of clinical operations experience in the pharmaceutical industry with at least 1 year experience managing industry-sponsored pharmaceutical clinical studies as a sponsor employee
• Senior Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 8 years of clinical operations experience in the pharmaceutical industry with 3+ years’ experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
• Significant knowledge of GCP/ICH guidelines and the clinical development process
• Ability to plan, organize and conduct clinical studies with minimum oversight
• Significant experience managing CROs and other vendors and assessing performance
• Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
• Strong organizational skills and the ability to balance changing priorities
• Strong interpersonal and communication (written and verbal) skills
• Demonstrated ability to work independently and as part of a multi-functional team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment

Preferred Qualifications:  

• Experience supporting Phase 1 and 2 clinical trials is preferred
• Oncology experience is highly preferred

Physical Requirements:  

• Ability to travel as needed (approximately 20%)
• Ability to work onsite 2 days/week at our Seattle, WA office
• Ability to sit for prolonged periods of time

Manager Level Salary Range: $125,000 - $150,000
Senior Manager Level Salary Range: $150,000 - $175,000

POSITION SUMMARY

The Associate Clinical Trial Manager is primarily responsible for supporting the operational management and oversight of Umoja’s clinical studies. This individual will work closely with Clinical Operations leadership, Medical Director(s), other cross-functional team members, and designated CROs to ensure the successful completion of assigned clinical study activities and project deliverables within specified quality, time, and cost parameters.

The ideal candidate brings clinical operations expertise in biotech and the ability to thrive in a fast-paced, entrepreneurial environment.

This role is ideally based out of our Seattle, WA location and is onsite at least 2 days/week. We are open to remote work within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Leads specific aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of Clinical Operations’ methodologies, organizational, project management and leadership capabilities
• Supports selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• May act as a country lead for large global studies, working under the guidance of the Clinical Trial Manager/Clinical Operations Leadership
• Tracks and ensures optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
• Contributes to the content and review of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Coordinates, files and tracks the distribution of study documents and creates and updates study reports
• Assists in the set up and oversight of the Trial Master File according to ICH- GCP and company SOPs
• Ensures all trial documentation is in a state of audit readiness
• Identifies, selects, and monitors performance of investigational sites
• Ensures accurate and timely site visit monitoring reports
• Develops and maintains strong working relationships with trial investigators and staff
• Assists in management of budgets and payments for investigative sites
• Coordinates with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Manages investigational product release packages and investigational product accountability
• May assist in clinical data review and query generation
• Actively participates in and contributes to the development of department initiatives aimed at improving efficiency and best practices
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Performs administrative tasks to support Clinical Operations and other team members, as needed

The successful candidate will have:

• Bachelor’s degree or equivalent in Life Sciences with at least 3-5 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
• Strong organizational skills and the ability to balance changing priorities
• Strong interpersonal and communication (written and verbal) skills
• Demonstrated ability to work independently and as part of a multi-functional study team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment

Preferred Qualifications:  

• Experience supporting Phase 1 and 2 clinical trials is preferred
• Oncology experience is preferred

Physical Requirements:  

• Ability to travel as needed (approximately 20%)
• Ability to work onsite 2 days/week at our Seattle, WA office
• Ability to sit for prolonged periods of time

Salary Range: $110,000 - $130,000

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

POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Specialist, Drug Product (DP) to support Manufacturing Operations at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role will collaborate with other functions to develop and establish the Drug Substance (DS) and Drug Product (DP) processes.  Primary job responsibilities include, but are not limited to, DS/DP processing equipment onboarding, qualification, and management, material management, personnel gowning, facility cleaning, authoring reviewing and executing batch records, production scheduling, training and/or leading staff, aseptic processing, vial visual inspection, and onboarding new manufacturing processes/products. This role will support routine Manufacturing Operations. This role will interact on a regular basis with internal process engineers, process sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in our matrix team environment.

This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.

This role will be fully onsite. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCCOUNTABILITIES:
Specific responsibilities include:  

• Mentor and coach junior associates during the authorship of controlled documents and standard operating procedures on behalf of Manufacturing Operations.
• Lead GMP Manufacturing operations on the floor when Manager is not present
• Perform on-the-job training of associates as a Qualified Trainer for DS/DP unit operations
• Execution of Fill/Finish procedures and systems in support of GMP manufacturing

• Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales.
• Observe, perform, and qualify on aseptic process simulations and initial internal technology transfer runs
• Able to pass visual acuity tests and drug product visual inspection qualification
• Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform aseptic manufacturing of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Proactively engage and collaborate with cross-functional partners to ensure timely and successful completion of DS/DP process simulations and initial internal technology transfer runs from Process Sciences to Manufacturing
• Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval.
• Perform equipment cleaning, as required, per routine maintenance events, and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices.
• Revise and/or create processing SOPs, equipment SOPs, and batch records
• Perform and participate in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ of Manufacturing equipment and systems.
• Perform and oversee aseptic processes, including but not limited to sterile filling of lentiviral DS/DP in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9).
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations.
• Perform and oversee material management activities related to the kitting of Bill of Materials items.
• Other duties as needed 

The successful candidate will have:

• Bachelor’s degree in a related biotechnology or life-sciences field with 6 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered
• GMP Drug Substance / Drug Product Filling experience
• Vial Visual Inspection experience
• Leadership experience such as informal team lead, trainer, etc.
• Experience receiving a technology transfer

Preferred Qualifications:  

• Viral vector experience is preferred
• Ability to troubleshoot issues of moderate scope independently
• Ability to independently develop work plans and schedules to ensure the timely completion of assignments and deliverables
• Demonstrated experience leading results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team. 

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time
• Ability to pass visual inspection eye exam
• Extensive use of laboratory equipment includes handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work evenings, holidays, and weekends as needed 
• Ability to work on call as needed

Hourly Range: $43.52 - $53.76. This is a non-exempt position and is overtime eligible.

POSITION SUMMARY

Umoja Biopharma is seeking a Senior Calibration Technician to support the calibration and maintenance of measurement instrumentation at our state‑of‑the‑art lentiviral vector development and manufacturing facility in Louisville, Colorado. Primary responsibilities include performing routine and non‑routine instrument calibrations supporting production, laboratory, and facilities operations.

The Calibration Technician works independently with minimal supervision to execute instrument calibrations for parameters including conductivity, pH, pressure, flow, temperature, speed, and mass in compliance with GxP and company quality standards. This role requires strong judgment and initiative to troubleshoot and resolve complex issues, as well as the ability to coordinate and oversee external service providers to ensure all work and documentation meet Umoja requirements.

This role is an on-site position based out of our Louisville, CO location 5 days/week.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Coordinate and oversee external calibration service providers, including review of calibration certificates and resolution of documentation or compliance issues.
• Perform routine and non‑routine calibration of GMP and non‑GMP instrumentation supporting laboratory, manufacturing, utility, and facilities systems, using industry‑standard tools and methods.
• Ensure calibration and maintenance activities are performed and documented in compliance with GxP requirements, internal procedures, and applicable standards (e.g., ISO, ANSI, NIST), maintaining audit‑ready records.
• Troubleshoot calibration failures and instrumentation performance issues, identify corrective actions and support investigations in collaboration with cross‑functional partners.
• Legibly and accurately document work performed in Umoja’s CMMS system in accordance with cGMP requirements in a timely manner.
• Optimize the time required to perform calibrations to minimize impact to routine operations.
• Contribute to continuous improvement efforts by identifying opportunities to optimize calibration execution, vendor performance, and site business processes.

The successful candidate will have:

• High School diploma or equivalent, preferably including hands-on or vocational school training and a minimum of five (5) years of experience as an instrument technician in a manufacturing environment OR an Associate’s degree in a technical field (instrumentation, controls, automation, electrical) with a minimum of three (3) years of relevant calibration or instrumentation experience.
• Hands‑on experience with advanced or specialized instrumentation such as RTDs and thermocouples, gas sensors, RH and differential pressure instruments, load cells, control valves, precision mechanical tools, and automated manufacturing equipment.
• Experience in GMP biopharmaceutical or cell and gene therapy manufacturing and/or testing facility.

Preferred Qualifications:

• Knowledge and understanding of cGMP (current Good Manufacturing Practices), Food and Drug Administration, current pharmaceutical industry standards, and/or other regulations.
• Experience in executing metrology systems and activities in pharmaceutical manufacturing or other regulated industries is preferred
• Experience executing single‑point and multi‑point calibrations in pharmaceutical manufacturing or other highly regulated environments.
• Independent and analytical thought process to evaluate options and make decisions (risk-based decision-making capability).
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.
• Proficient in the operation of building automation systems including BMS, EMS, and standalone PLCs required for proper building, equipment, and system operation.
• Experience working with Blue Mountain Regulatory Asset Manager CMMS is highly preferred.
• Experience reading P&IDs, electrical drawings, schematics, and equipment manuals.

Physical Requirements:  

• Ability to work onsite every day.
• Ability to work evenings and/or holidays as needed
• Ability to wear personal protective equipment (PPE) including gloves, protective clothing, and eye safety glasses.
• Ability to perform physical tasks including standing, use of hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.

Hourly Range: $40.46 - $49.98 This role is non-exempt and is overtime eligible.

POSITION SUMMARY

Umoja is seeking a Head of Drug Product Development to join the Process Sciences team. This position will provide leadership for internal and external drug product manufacturing processes for lentiviral vectors, including formulation development, fill-finish and technology transfer activities for early and late-stage programs. Additionally, this position will lead the process aspects of a facility capital project to upgrade internal fill-finish manufacturing.

A successful candidate should have a thorough understanding of formulation development and fill-finish strategies and approaches for both early and late-stage products along with strong communication and collaboration skills to partner with leaders across Umoja.

This is a fully onsite role based at our Louisville, CO location with some expected travel. The level of this role will be determined based on candidate’s experience and qualifications.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Build, mentor, and lead a high-performing Drug Product and Formulation team comprised of Scientists and Engineers including recruiting, performance management, and talent development
• Lead the Drug Product Development team activities for multiple products, including new product introduction for early phase formulation development, internal and external technical transfer, manufacturing support and clinical trial support for a frozen-in-vial lentiviral drug product
• Serve as the primary technical point of contact for external fill-finish technical transfer
• Drive the late-stage Drug Product Development strategy for formulation development, process qualification for manufacturing
• Lead and serve as the primary technical point of contact for a fill-finish capital project to improve Umoja’s internal manufacturing capability
• Lead formulation and process improvements to stability, final filtration and dosage form
• Collaborate closely with the Process Sciences team (upstream, downstream and optimization), analytical development, manufacturing, supply chain, non-clinical, clinical and research teams
• Proactively communicate Drug Product Development strategy, plans, risks and mitigations to senior internal and external leaders
• Serve as Drug Product Development and/or Process Sciences subject matter expert for Program Teams and Governance
• Maintain familiarity with current scientific literature, experimental methods and manufacturing approaches

The successful candidate will have:

• Director Level: PhD/MS/BS in Biochemistry, Chemical Engineering, Bioengineering, Biology or related field with 10/12/15 years of relevant experience, respectively. Equivalent combination of education and experience will be considered. Minimum 6 years of people management experience.
• Senior Director Level: PhD/MS/BS in Biochemistry, Chemical Engineering, Bioengineering, Biology or related field with 15/17/20 years of relevant experience, respectively. Equivalent combination of education and experience will be considered. Minimum 10 years of people management experience.
• Extensive experience with early and late phase fill-finish process and formulation development, stability, clinical and regulatory expectations, including IND and BLA authoring and/or strategy
• Extensive experience with technical transfer and GMP manufacturing support, including Process Performance Qualification (PPQ)
• Experience with fill-finish capital projects and practical/working knowledge of EU GMP Annex 1 guideline
• Strong knowledge of drug product characterization, accelerated stability, container-closure selection and analytical methods
• Strong team and executive level communication and collaboration skills, along with self-motivation to contribute to the development of novel cancer immunotherapies
• Ability to balance multiple priorities in a fast-paced, cross-functional and dynamic environment and perform tasks across a variety of levels

Preferred Qualifications:  

• Strong understanding of sub-visible and sub-micron particle measurement and characterization
• Understanding and experience with viral drug products, preferably BSL2 or higher enveloped viruses
• Working knowledge of clinical supply chain
• Upstream, Downstream or other Process Development or Manufacturing experience
• PUPSIT process development, implementation and qualification
• Analytical method development experience, including stability indicating assay development
• Experience with frozen-in-vial and lyophilized/spray dried drug products
• Experience leading extractable and leachable studies
• Familiarity with small-molecule drug substance and drug product formulation and fill-finish

Physical Requirements:  

• 100% compliance with personal protective equipment (PPE) requirements in biological laboratory environments for wet lab work, 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.
• Project-oriented work in this role will require regular on-site presence to complete essential job-related functions.
• Ability to travel up to 20%

Director Level Salary Range: $197,300 - $243,700

Senior Director Level Salary Range: $233,500 - $288,400

POSITION SUMMARY

We are seeking a passionate and capable Associate Manager to support Purification Operations within our Manufacturing team for our early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role is responsible for leading the operations and continuous improvement of manufacturing programs and operating systems in downstream and solution preparation.  Primary job responsibilities include, but are not limited to, new hire onboarding, personnel development, purification unit operation execution, equipment maintenance, material management, personnel gowning, implementing personnel/material flow, batch records review, production scheduling, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful downstream execution, personnel staffing finite coverage, personnel development, and continuous improvement initiatives implemented.

This role will interact on a regular basis with internal process engineers, Process Sciences, Facilities, Supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in this matrix environment.

This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies. 

This role will be fully onsite at our Louisville, CO location. The schedule for this role will be determined upon offer extension. It will either be Monday-Friday, 8 am to 5 pm or a 4x10 schedule with an option of Monday-Thursday or Tuesday-Friday. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCOUNTABILITIES

Specific responsibilities include: 

• Manage, mentor, and develop a team of high performing manufacturing associates at varied levels.
• Leads the execution and improvement of compliant manufacturing process procedures, programs, and systems in support of GMP manufacturing operations
• Authors and reviews-controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Actively partners with Process Sciences to lead successful technology transfer of novel cell/gene therapy manufacturing processes at various scales, with a focus on purification process steps (i.e., chromatography, TFF, buffer prep).
• Assists in deviation investigations
• Leads activities related to the introduction of new raw materials specifications from draft through approval
• Ensures adherence to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Responsible for ensuring personnel training qualification and trainer status to enable operations
• Participates in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ/PQ of Manufacturing equipment and systems
• Performs aseptic manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Ensures maintained inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Leads solution and buffer prep operations in a clean-room environment (ISO9)
• Ensures development of operating schedules and ensures schedule adherence for manufacturing task execution
• Hiring and onboarding any new team members required to meet goals
• On-the-floor Manufacturing support and execution as needed approximately 50% of time
• Other duties as needed

The successful candidate will have:

• Associate Manager Level: Bachelor’s degree in a related life-science field, or equivalent in work experience with 8+ years of cGMP manufacturing experience in the pharmaceutical, biologics, and/or medical device field is desired or equivalent in work experience or education with a minimum of 2 years of people management experience.
• Manager Level: Bachelor’s degree in a related life-science field, or equivalent in work experience with 10+ years of cGMP manufacturing experience in the pharmaceutical, biologics, and/or medical device field is desired or equivalent in work experience or education with a minimum of 4 years of people management experience.
• Prior experience in the downstream purification areas of chromatography and tangential flow filtration
• Prior experience in Weigh and Dispense and solution preparation areas
• Prior management/team leadership experience in a manufacturing environment

Preferred Qualifications:

• Prior experience receiving a technology transfer is strongly preferred
• Prior commercial manufacturing experience is strongly preferred
• Commercial launch and audit experience
• Prior experience assisting in deviation investigations and CAPAs
• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team.

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment
• Ability to work while gowned for extended periods of time
• Extensive use of laboratory equipment includes handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work holidays, nights and weekends as needed

Salary Range:

Associate Manager Level- $107,100 - $132,300

Manager Level - $125,300 - $154,800

POSITION SUMMARY

The Senior Director, Clinical Data Management will provide strategic and operational leadership for all clinical data management activities across Umoja’s clinical development programs. This role sits within the Clinical organization and is accountable for ensuring the integrity, quality, and regulatory compliance of clinical trial data from protocol development through database lock and regulatory submission.

This individual will lead the planning, execution, and oversight of data management activities, clinical systems, and external vendors, while building scalable processes and capabilities to support a growing clinical pipeline. The role partners closely with Clinical Development, Clinical Operations, Biostatistics, Translational Medicine, Regulatory Affairs, and external partners like CROs to ensure timely delivery of high quality, decision-read‑y‑ clinical data.

This role will be an Individual Contributor and will lead a matrixed team of vendors (CROs) and contractors to start. This person will be responsible for building out a future team.

This role will ideally be based in Seattle, WA or Louisville, CO but can be remote within the US. If remote, travel to Umoja Headquarters will be required at least once per quarter.

CORE ACCOUNTABILITIES

Specific Responsibilities include:
Hands‑On Clinical Data Management Execution (as needed while building CDM team)

• Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
• Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.
• Lead hands-on CRF design and review, ensuring alignment with protocol objectives‑, statistical analysis plans, and regulatory expectations.
• Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.
• Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
• Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready‑ datasets.

Technical Oversight & Data Quality

• Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based‑monitoring approaches for clinical data.
• Lead hands-on‑oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.
• Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming.
• Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
• Support inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findings.

Cross Functional Collaboration

• Partner closely with Clinical Operations to align data management activities with study execution, site operations, monitoring strategies, and operational reporting needs.
• Collaborate with Biostatistics and Statistical Programming to ensure smooth handoff of clean, well documented- datasets for analysis and reporting.
• Provide technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissions.
• Serve as the clinical data management subject matter‑ expert on study teams, governance forums, and internal reviews.

Process & Systems Ownership

• Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.
• Evaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, IRT, eCOA) to enhance data quality, traceability, and scalability.
• Contribute hands‑on to vendor selection, scope definition, and budgeting for data management services and systems.

The successful candidate will have:

• Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be considered.
• Significant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials.
• Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.
• Strong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical data.
• Proven ability to lead teams, manage complex programs, and collaborate effectively in a fast‑paced, matrixed environment.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience supporting oncology and/or cell or gene therapy clinical development programs.
• Experience building or scaling clinical data management capabilities in a growing biotech organization.
• Prior involvement in regulatory submissions and inspection readiness activities.

Physical Requirements

• Preference to work onsite at least 2 days/week in our Seattle, WA or Louisville, CO location. If remote, the ability to travel to Seattle, WA at least once per quarter.
• Ability to sit for prolonged periods of time.

Salary Range: $247,400 - $305,600

POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Associate 1 to support Manufacturing Drug Substance (DS) / Drug Product (DP) Operations at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role will support routine Manufacturing DS/DP Operations and primarily be focused on the DS/DP Fill & Visual Inspection of our process, however, could be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to, manufacturing equipment onboarding, material management, personnel gowning, following personnel/material flow, executing batch records, aseptic processing, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful aseptic manufacturing training/qualification and execution to create phase1 lentiviral drug products. This role will interact on a regular basis with internal process engineers, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in our matrix team environment.

This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.   

This role will be fully onsite at our Louisville, CO location. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCOUNTABILITIES
Specific responsibilities include:    

• Execution of Fill/Finish procedures and systems in support of GMP manufacturing
• Participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Observe, perform, and qualify on aseptic process simulations
• Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval
• Perform equipment cleanings, as required, per routine maintenance events and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Perform aseptic manufacturing of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to kitting of Bill of Materials items
• Other duties as needed 

The successful candidate will have:

• Bachelor’s degree in a related biotechnology or life-sciences field; OR Associate’s degree in a related biotechnology or life-sciences field with 2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered

Preferred Qualifications: 

• Prior aseptic technique experience is strongly preferred
• Prior GMP experience is preferred 
• Prior experience receiving a technology transfer is preferred 
• Aseptic cell culture experience is a bonus 
• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team. 

Physical Requirements:    

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time 
• Use of laboratory equipment including handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work nights and weekends as needed 
• Ability to be on call as needed.

Salary Range: $26.03 - $32.16/hour. This is a non-exempt role and is overtime eligible.

POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Associate 2 to support Manufacturing Drug Substance (DS) / Drug Product (DP) Operations at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role will support routine Manufacturing DS/DP Operations and primarily be focused on the DS/DP Fill & Visual Inspection of our process, however, could be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to: manufacturing equipment onboarding, qualification, and management, material management, personnel gowning, implementing personnel/material flow, executing batch records, aseptic processing, vial visual inspection, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful aseptic manufacturing training/qualification and execution to create phase1 lentiviral drug products. This role will interact on a regular basis with internal process engineers,  facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in our matrix team environment.

This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.   

This role will be fully onsite at our Louisville, CO location. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCOUNTABILITIES
Specific responsibilities include:    

• Execution of Fill/Finish procedures and systems in support of GMP manufacturing
• Participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Observe, perform, and qualify on aseptic process simulations and initial internal technology transfer runs
• Able to pass visual acuity tests and drug product visual inspection qualification
• Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval
• Perform equipment cleanings, as required, per routine maintenance events and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform aseptic manufacturing of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to kitting of Bill of Materials items
• Other duties as needed 

The successful candidate will have:

• Bachelor’s degree in a related biotechnology or life-sciences field with 2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR Associate’s degree in a related biotechnology or life-sciences field with 4 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered
• GMP experience
• Aseptic technique or Fill/Finish experience

Preferred Qualifications: 

• Prior experience receiving a technology transfer is preferred 
• Aseptic cell culture experience is preferred
• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team. 

Physical Requirements:    

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time 
• Ability to pass visual inspection eye exam
• Extensive use of laboratory equipment including handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work nights and weekends as needed 
• Ability to work on call as needed

Salary Range: $30.05 - $37.12/hour. This is a non-exempt role.

POSITION SUMMARY

We are seeking a passionate and capable Materials Handler to join our Supply Chain team. As a member of the Supply Chain group, you will be working with many departments, such as Manufacturing, Quality, and Laboratory Materials groups to ensure that all the material needs of the business are met.

The Materials Handler will be primarily tasked with receipt, stocking, inventory management, and data entry for materials to support pre-clinical/tox/engineering and GMP manufacturing activities. Certain activities will be managed by Standard Operating Procedures (SOPs), and the Materials Handler must ensure that they are able to follow all SOPs and work instructions.

The successful candidate will partner closely with stakeholders to anticipate needs, resolve issues quickly, and deliver a consistent, high-quality service-based experience. We are looking for someone who takes ownership, communicates clearly, and works collaboratively to ensure our partners receive timely and effective support.

Additional activities may include communication with Umoja teams and feedback on warehouse processes. Ideal candidate will have good communication skills, be highly organized, and detail oriented.

Prior experience with a GMP environment and experience driving a forklift highly preferred.

This role will support supply chain activities, reporting to the Warehouse Manager onsite 5 days/week in Louisville, CO.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Correct and timely receipt and processing of GMP and non-GMP materials at The CLIMB warehouse in Louisville, CO.
• Maintaining a safe, clean, and orderly warehouse in support of manufacturing activity
• Overseeing Raw Material kitting and transfer
• Cycle counting warehouse inventory and maintaining high accuracy with data entry
• Operating the warehouse according to and in compliance with Umoja SOPs and Quality Systems
• Safely operating machinery such as forklifts and order pickers
• Collaborating with other departments like Manufacturing, Quality, and Laboratory Materials to ensure all material needs are met
• Demonstrate proactive, service-oriented mindset and the ability to work effectively with cross functional partners.
• Demonstrating the Umoja Values of Unified in Purpose, Meaningful Impact, Obsessed with Solutions, Joyful, and Accountable.

The successful candidate will have:

• A GED or equivalent degree with at least 2 years of experience in a Supply Chain/Warehouse/Inventory Role
• High attention to detail and excellent organizational skills
• Excellent communication skills
• Proficiency with Microsoft Office suite

Preferred Qualifications:  

• Forklift operating license
• Experience with NetSuite or other Inventory management software
• Experience operating in a cGMP environment

Physical Requirements:  

• Ability to lift, push, pull, and carry to 50 lbs
• Comfortable being on your feet for extended periods of time.
• Exposure to warehousing and manufacturing areas at +5°C including storage freezer at –20°C
• Adherence to wearing proper personal protective equipment (PPE) such as but not limited to safety vest, eye protection (when required), cold/cut proof gloves (when required), steel-toed shoes, manufacturing gowning, line harness, and fall protection.

Hourly Range: $25.79 - $31.85 (This role is non-exempt and is overtime eligible.)

POSITION SUMMARY

We are seeking a passionate and capable Sr. Bioprocessing Associate to support downstream Manufacturing Operations at our early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. This role will support routine Manufacturing Operations and primarily focus on the downstream purification of our process, however, could be expected to support other manufacturing functions as well.

Primary job responsibilities include, but are not limited to, executing buffer prep, chromatography, and TFF batch records, material management, personnel gowning, adhering to personnel/material flow, facility cleaning, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by full qualification on downstream manufacturing unit operations and successful execution to create lentiviral drug products.

This role will interact on a regular basis with internal process engineers, Process Sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in our matrix team environment. This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.    

This is a fully onsite role at our Louisville, CO site. This role will start as 5 days/week and convert to a 4x10 schedule after completing onboarding/training.

CORE ACCOUNTABILITIES

Specific responsibilities include:    

• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices. Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform weigh/dispense and buffer prep operations in a clean-room environment (ISO9)
• Observe, participate, and perform in downstream unit operation execution, and initial internal technology transfer runs from Process Sciences to Manufacturing
• Assist in the implementation of compliant and technically sound programs and systems in support of GMP manufacturing 
• Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Perform activities related to the introduction of new raw materials specifications from draft through approval
• Perform equipment cleanings, as required, per routine maintenance events, and pre/post process requirements.
• Perform aseptic manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to kitting of Bill of Materials items
• Other duties as needed  

The successful candidate will have:

• Associate’s degree/Bachelor’s degree in a related biotechnology or life-sciences field with 5/3+ years of cGMP manufacturing experience (respectively) in the pharmaceutical and/or biologics field is desired or equivalent in work experience or education 
• Prior Commercial GMP manufacturing experience is required 
• Downstream purification knowledge or experience is required (e.g., depth-filtration, tangential flow filtration, and/or chromatography), specifically Cytiva’s AKTA Ready and Repligen’s KMPi systems. 

Preferred Qualifications: 

• Prior Commercial launch GMP manufacturing experience preferred
• Prior experience receiving a technology transfer is a bonus 
• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team.  

Physical Requirements:    

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time 
• Extensive use of laboratory equipment includes handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work nights and weekends as needed  
• Ability to work holidays and on-call as needed

Salary Range for Senior Bioprocessing Associate: $36.06 – $44.57/hour This is a non-exempt role.

Salary Range for Bioprocessing Associate II: $30.05-$37.11/hr This is a non-exempt role.

POSITION SUMMARY

The Medical Director will serve as a clinical leader, providing medical and scientific expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in clinical strategy, study design, execution, and regulatory interactions while partnering cross-functionally with R&D, Clinical Operations, Regulatory, and Program Leadership teams. The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology clinical development.

We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs.
• Contribute to the clinical development strategy, including indication selection, trial design, and endpoints.
• Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements.
• Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents.
• Partner with Clinical Operations on trial execution, including site and investigator engagement, medical monitoring, and data review.
• Engage with global regulatory agencies to support program advancement.
• Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
• Collaborate closely with translational medicine, preclinical, and regulatory teams to align clinical strategy with scientific discoveries.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.

 The successful candidate will have:

• Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. 2-5 years of clinical development experience, including at least 2 years in the biotechnology or pharmaceutical industry.
• Senior Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. Minimum of 5 years of clinical development experience, including at least 4 years in the biotechnology or pharmaceutical industry.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus.
• Direct experience in oncology clinical trial design, execution, and medical monitoring.
• Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
• Proven ability to interact with investigators, KOLs, and regulatory authorities.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Passion for innovation and commitment to advancing transformative therapies for patients.

Physical Requirements:  

• Ability to travel at least 6x per year to site initiation visits, domestic and international conferences, ad boards, etc
• Ability to work onsite at least 2 days/week

Director Salary Range: $250,000 - $313,000
Senior Director Salary Range: $270,000 - $333,000

POSITION SUMMARY

The Senior Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja’s drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading HA meetings). In this role, the Senior Director will be the Regulatory Affairs leader on program teams and will provide expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in regulatory strategy, study design, execution, and in leading regulatory interactions.

The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology drug development.

This role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs. It builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

We will consider candidates at either the Senior Director or Executive Director level based on candidate's qualifications and experience.

CORE ACCOUNTABILITIES 

Specific responsibilities include:  

• Independently provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints, to support program advancement.
• Develop registration strategies and plans (e.g., TPP development and assessment) to achieve regulatory approvals and desired product labeling.
• Lead global regulatory filings (IND/CTA/BLA/MAA submissions), setting strategy for submissions of product registration documents for health authorities worldwide.
• Primary point of contact with global regulatory agencies to support program advancement.
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders (as relevant).
• Identify, communicate, and propose resolutions to both routine and complex issues.
• Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
• Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams to align overall strategy with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. Provide interpretation of regulatory authority feedback, policies, guidelines, and directives.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.
• Provide organizational support and mentoring as company grows its product development pipeline.

The successful candidate will have:

• Senior Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs. Experience in Oncology, Hematology, or related specialty strongly preferred. Successful track record of regulatory submissions and approvals.
• Executive Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 15/18/18+ years, respectively, of relevant experience in regulatory affairs. Experience in Oncology, Hematology, or related specialty strongly preferred. Successful track record of regulatory submissions and approvals.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred; experience in in vivo gene delivery a plus.
• Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
• Proven ability to interact with regulatory authorities.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Passion for innovation and commitment to advancing transformative therapies for patients.

Physical Requirements:  

• Ability to travel (~20%) for team meetings and/or regulatory interactions as required. Some international travel possible.
• Ability to sit for prolonged periods of time

Senior Director Salary Range: $253,000 - $312,500
Executive Director Salary Range: $272,900 - $337,000