About Kamau Therapeutics, Inc.

Kamau Therapeutics is a clinical-stage biotech founded by a deeply collaborative team of hematologist-oncologists and engineers. We are pioneering a precision homology-directed repair (HDR) gene editing platform to create definitive autologous hematopoietic stem cell (HSC) therapies. Our mission begins with our lead program: a first- and best-in-class curative treatment for sickle cell disease (SCD). This program now serves as our powerful proof point, establishing a core competence in site-specific genome editing of HSCs. We are next leveraging this mastery to engineer myeloid and lymphoid lineages, fueling a growing pipeline of next-generation therapies for cancer immunotherapy, autoimmune disease, and neurodegeneration. We operate with a high-impact, collaborative spirit, focused on redefining the speed and reach of therapeutic development.

Role Summary

This is a key role within Analytical Development at Kamau, joining our growing analytical function. The successful candidate will design, qualify, and, ahead of BLA, validate the assays that make potency and other appropriate assays, the existential and company-defining measurement for our lead HSC gene-editing program, nula-cel, a defensible, inspection-ready release test in advance of the upcoming pre-pivotal regulatory milestone. Our operating principle is that Kamau owns analytics, process knowledge, and quality decisions, and our CDMO makes the product. This role contributes to the Analytical Development function, including coaching and mentoring junior scientists as the team grows, and serves as a technical authority on potency and analytical strategy across the organization. The successful candidate also contributes to the analytical platform and strategy for our next-generation pipeline and represents analytical science to cross-functional teams, the Board, and regulators as needed.

This is a ‘roll-up-your-sleeves’ role for a builder who thrives in a fast-paced and highly collaborative startup environment. The ideal candidate approaches work with curiosity, humility, and a growth mindset, taking initiative and contributing across functions and levels. At Kamau, we’re building a mission-driven culture where scientific rigor, creativity, and collaboration power both personal and company growth.

Key Responsibilities

• Contribute to the growth of the Analytical Development function: help shape analytical strategy for the program, the assay portfolio, and method-lifecycle strategy as the function scales.
• Coach and mentor junior scientists, sharing expertise in potency assay development, qualification, and data integrity practices, and help raise the technical and documentation standards of the team.
• Own development, qualification, and ICH Q2 validation of the release and characterization panel and define the multi-attribute potency matrix combining molecular and functional measures: editing outcomes by ddPCR, NGS-based off-target and genomic integrity assessment, erythroid differentiation and hemoglobin analysis, colony-forming potency, flow-cytometry identity and purity, viability and counting, residual component clearance, and safety testing.
• Contribute to the analytical platform strategy for the next-generation pipeline (myeloid and lymphoid lineage programs), ensuring that potency, characterization, reference-material, and data strategies are phase-appropriate, reusable across programs, and defensible with regulators.
• Define molecular and functional critical quality attributes, set specifications on a statistical basis, author the justification of specification for drug substance intermediate and final drug product, and defend them in regulatory interactions: what gates release versus what is managed in-process or as characterization-only and set method acceptance and system-suitability criteria.
• Design comparability protocols with pre-specified equivalence criteria for process-version bridging, site changes, and method bridging when analytical procedures change.
• Establish and maintain a tiered reference standard program, assay controls, and critical analytical reagents, including qualification and lot-to-lot bridging; lead critical-reagent variability investigations and define supplier impurity profiles and acceptance limits.
• Own method transfer, qualification, and ongoing oversight at CRO/CDMO laboratories, including outsourced molecular and cytogenetic analytics; set technical governance and quality-agreement expectations for analytical work at partners; and build the strategy and readiness for transition of methods to commercial QC.
• Own method performance monitoring and analytical investigations: control trending, invalid and repeat rates, periodic review, and OOS/OOT root cause and CAPA.
• Own and lead authorship of the relevant analytical sections of Module 3, control of drug substance and drug product, analytical procedures and validation, reference standards, and stability, and lead responses to health-authority information requests through review, including representing Analytical Development in regulatory meetings.
• Support analytical readiness for pre-approval inspection: raw data traceability, validation packages, analyst qualification records, and CRO/CDMO analytical documentation.
• Lead/Contribute to running the AD laboratory and function, including equipment and software qualification, data integrity and GxP compliance, reagent supply, safety, and CRO selection and governance.
• Support PPQ through analytical sampling plans, in-process control testing, and release of validation lots; coordinate with Process Development and MSAT so assay readiness aligns with process lock; and contribute analytical risk assessments (FMEA) and critical-path inputs to CMC program and submission planning.
• Represent Analytical Development on cross-functional teams and with the Board and external partners as needed, and maintain compliance with laboratory safety, quality standards, and company SOPs.
• Partner with the CTO, Regulatory, Quality, and Clinical leadership to align analytical strategy with corporate and regulatory objectives, including technical due diligence as needed.

Required Qualifications

• PhD in molecular biology, biochemistry, immunology, or a related field with 8+ years of experience; or MS with 12+ years; or BS with 14+ years, in analytical development for biologics, cell or gene therapy.
• Direct hands-on experience developing, qualifying, and validating potency assays for cell and/or gene therapy products, with working familiarity across NGS, ddPCR, qPCR, flow cytometry, and colony-forming assays.
• Experience carrying an analytical package into a late-stage or registrational filing, including authorship of Module 3 analytical sections and responses to health-authority questions. Has represented analytical or potency strategy directly to FDA as the lead analytical speaker (e.g., Type B, Type C, or pre-BLA meetings, or information-request teleconferences).
• Demonstrated people-leadership experience, including hiring, performance management, and developing scientists; experience building or substantially growing a function is strongly preferred.
• Working knowledge of phase-appropriate analytical strategy and of ICH Q2 validation, Q14 analytical procedure development, Q5E comparability, Q6B specifications, and Q5C stability, plus current regulatory expectations for potency assurance in cell and gene therapy.
• Experience authoring and executing analytical method transfer protocols with a CRO/CDMO QC laboratory, including precision and reproducibility study designs.
• Familiarity with data integrity expectations (ALCOA+, 21 CFR Part 11) and validated laboratory systems.

Preferred Qualifications

• Experience with gene-editing analytics in hematopoietic stem cells or other primary cells.
• Experience supporting a pre-approval inspection or regulatory inspection of an analytical laboratory or CRO.
• Experience designing stability programs and justifying shelf-life or retest dating for cryopreserved cell products.
• Statistical fluency, equivalence testing, measurement systems analysis, design of experiments, and comfort with tools such as JMP.
• Experience owning a function budget and CRO contracts.

The Right Candidate Will

• Be a high-agency, do-what-it-takes contributor. You don’t wait for instructions; you identify the critical path, flag risks, and build solutions.
• Be relentlessly output focused. You are driven by delivering robust, defensible methods, not by ‘doing tasks or processing for its own sake.
• Be a fluid and pragmatic collaborator. You understand that in a small company, titles are secondary to the mission. You are eager to contribute across functions and levels.

Compensation

The expected base salary range for this position is $230,000-$287,000 per year.

Actual compensation will depend on qualifications, experience, and internal equity. This position is also eligible for an annual target bonus and equity in the form of stock options.

In addition to base salary and equity, we offer a comprehensive Total Rewards program including health, dental, and vision coverage, retirement benefits, and paid time off.

Work Requirements

The role is based in South San Francisco and/or Redwood Shores, CA, requires five days per week onsite and involves periodic travel within the US to CDMOs to support project demands. This role is performed in a laboratory environment and requires the ability to perform detailed bench work, gown and work in controlled environments with required personal protective equipment, handle cryogenic materials with appropriate protection, sit or stand for extended periods, and occasionally lift up to 25 pounds. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of the role.

Equal Employment Opportunity

Kamau Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law, and we are committed to providing reasonable accommodations to applicants and employees with disabilities.

Additional Information

Employment is contingent on a background check conducted only after a conditional offer. Consistent with the California Fair Chance Act, we consider qualified applicants with criminal histories and conduct an individualized assessment of any conviction history. Kamau Therapeutics participates in E-Verify. See our Applicant Privacy.

Disclaimer

This job description is intended to describe the general nature and level of work performed and is not an exhaustive list of all responsibilities, duties, or qualifications associated with the role.

Recruiter Policy

Kamau does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, Kamau will not consider or agree to payment of any referral compensation or recruiter fee.

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