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

Kamau Therapeutics is seeking a motivated Analytical Development and Quality Control Scientist to join our growing team. The successful candidate is a hands-on contributor responsible for developing, qualifying, and executing the analytical methods that characterize and release our clinical product. Working under the guidance of the Director, Analytical Development, and alongside senior team members and external CRO/CDMO partners, you will help translate analytical strategy into reliable, inspection-ready test methods.

This is a ‘roll-up-your-sleeves’ role for a builder who thrives in a fast-paced, unstructured, 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

• Support the development, qualification, and validation of potency and release methods, including precision, accuracy, specificity, linearity, and range studies.
• Execute development, characterization, and stability testing under GMP-aligned practices, including colony-forming functional potency, erythroid differentiation and hemoglobin analysis, flow-cytometry cell enumeration, and cell concentration and viability testing.
• Support GMP release testing performed at our CDMO and contract laboratories through oversight and data review, rather than making independent release decisions.
• Run day-to-day potency assay setup, editing outcomes by ddPCR, methylcellulose plating, colony scoring by morphology, erythroid differentiation/hemoglobin measurement assays and data capture; troubleshoot plating density, dehydration, and image-quality issues.
• Execute flow-cytometry enumeration per applicable compendial and industry guidance, including compensation setup, bead-based absolute counting, isotype controls, and system-suitability controls.
• Author qualification, transfer, stability, and investigation reports, and contribute to CMC documentation for regulatory submissions, including IND amendments and BLA sections.
• Assist with method transfer and qualification at CRO/CDMO partners, including protocol execution, sample shipment, and reconciliation of returned data.
• Contribute to CMC documentation for regulatory submissions, and support authorship of qualification, validation, and investigation reports.
• Manage the banked retains and stability samples used for qualification and stability studies: receipt, accessioning, chain-of-custody, cryogenic storage and retrieval, retains, and accountability.
• Maintain GMP documentation to good documentation practice standards and perform second-person review of peer data.
• Review results against approved specifications and system-suitability criteria; escalate atypical, OOS, and OOT results and support laboratory investigations with Quality Assurance.
• Manage the qualification, expiry tracking, and inventory of analytical reagents, controls, and reference materials. Conduct lot-to-lot comparability and impurity-profiling studies on critical reagents. Advance laboratory efficiency through supply oversight, equipment calibration and maintenance, and workflow optimization.
• Represent AD/QC on cross-functional teams with Process Development, Manufacturing, Quality Assurance, and Clinical, and maintain compliance with laboratory safety, quality standards, and company SOPs.

Required Qualifications

• BS with 5+ years of hands-on experience in analytical development, quality control, or CMC within cell/gene therapy; hands-on development or qualification of cell-based assays, an MS with 3+ years or a PhD with 0-2 years of industry exposure will also be considered.
• Working knowledge of GMP laboratory practice, including good documentation practice, second-person review, and execution of approved test methods.
• Familiarity with analytical techniques and troubleshooting routine techniques such as flow cytometry, viability and potency assays, colony-forming unit (CFU) assays, erythroid differentiation or hemoglobin analysis, PCR/qPCR/ddPCR, or biochemical assays.
• Experience with data analysis software (e.g., JMP, FlowJo) and electronic lab notebooks or LIMS.
• Familiarity with data integrity expectations (ALCOA+, 21 CFR Part 11).
• Familiarity working in eQMS systems
• Strong organizational skills, with the ability to track projects, coordinate with partners, and generate high-quality documentation.

Preferred Qualifications

• Working knowledge of primary cells or hematopoietic stem cells.
• Exposure to method qualification or validation studies and to ICH Q2 principles.
• Familiarity with methylcellulose-based colony plating and colony morphology classification (BFU-E, CFU-E, CFU-GM, CFU-GEMM).
• Exposure to OOS/OOT handling, laboratory investigations, and equipment calibration records, and comfort with aseptic technique and cryogenic sample handling.

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 a robust, scalable process, not by ‘doing tasks’ or process 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 $125,000-$160,000 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 may involve 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 Notice.

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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