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

As Kamau ramps toward PPQ and BLA inspection-readiness, this role builds out the quality function alongside the Associate Director of Quality Assurance, taking ownership of batch-record review and the documentation backbone for product release. The role will own/support batch-record second review, specification version control, release data reconciliation, document control and training, and the build of the inspection-readiness program. This is a hands-on role with real scope for growth: the successful candidate will help shape how quality operates here as the company scales from clinical supply through BLA.

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

• Perform batch-record review for CDMO-executed GMP manufacturing runs, escalating discrepancies per established procedures.
• Author SOPs and WKIs for various internal procedures to support CDMO functions.
• Own specification version control and reconcile release data against the effective product specifications, confirming that test methods, test sites, and acceptance criteria match the approved specification version.
• Support deviation, CAPA, and change-control documentation and tracking as lot volume increases through PPQ.
• Support review and approval of CDMO-authored test methods, method transfer and qualification protocols, and test data records, including external approval routing.
• Support inspection-readiness activities ahead of BLA, including documentation organization and gap assessments.
• Support deployment and day-to-day administration of the electronic quality management system (Dot Compliance) as the company moves off paper-based tracking.
• Support vendor and CDMO quality accountability, including quality agreement adherence, supplier quality documentation review, and follow-through on supplier-related quality events.
• Track quality metrics and documentation status across manufacturing campaigns, and support quality-related sections of CMC documentation as needed.
• Assist with document control, training coordination, and SOP maintenance as the quality function scales, and maintain compliance with company SOPs and applicable GMP quality standards.

Required Qualifications

• BS in a life science, engineering, or related field with 2–5 years of GMP quality assurance experience, ideally in cell or gene therapy or biologics.
• Hands-on experience with batch-record review and deviation investigations/CAPA documentation.
• Familiarity with eQMS and validated EDMS platforms (Dot Compliance, Veeva, MasterControl, TrackWise, Qualio or equivalent), controlled document lifecycles, and external approval workflows with CDMO partners.
• Strong attention to detail, with the ability to manage a high volume of documentation accurately in a fast-paced, scaling environment.

Preferred Qualifications

• Comfort reviewing cell and gene therapy release panels (flow cytometry, potency, safety, and molecular assays) and identifying discrepancies between the specification, the test method, and the reported result.
• Exposure to inspection-readiness activities or regulatory inspections.
• Familiarity with CDMO-based manufacturing models and external partner documentation.

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 $100,000–$135,000 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. It requires five days per week onsite and involves occasional travel within the US to CDMOs to support project demands. This role is primarily performed in an office environment, with periodic time in laboratory and GMP manufacturing areas requiring gowning and appropriate personal protective equipment.

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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