Principal Engineer / Senior Engineer, MSAT South San Francisco and/or Redwood Shores, CA (onsite)

About this role

Principal Engineer / Senior Engineer, MSAT

Location:

South San Francisco and/or Redwood Shores, CA (onsite)

Reports to:

Chief Technology Officer

Travel:

Travel to CDMOs and suppliers (30-50%) to maintain an active in-person plant presence is essential to ensuring right-first-time execution of all manufacturing-related activities.

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 role is a key technical presence at Kamau’s CDMO, working as part of a growing MSAT team. The MSAT Engineer is expected to hit the ground running: begin supporting technology transfer, help drive the process through engineering runs and process characterization toward a PPQ-ready process, and contribute to process validation data and CMC content that support BLA submission shortly thereafter. Serving as person-in-plant, the successful candidate oversees engineering and PPQ runs on site, reviews batch data in real time, partners with the CDMO’s manufacturing and quality teams, and owns key workstreams in the technology transfer of our next-generation process. It is a high-visibility, high-ownership seat with direct influence over how our product is made.

Travel to CDMOs and suppliers (30–50%) to maintain an active in-person plant presence is essential to ensuring right-first-time execution of all manufacturing-related activities.

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

• Serve as a key technical presence at the CDMO from day one: begin supporting technology transfer within the first 30 days and provide on-site oversight and real-time troubleshooting during GMP engineering and PPQ manufacturing campaigns. Act as the day-to-day technical point of contact, resolving routine questions quickly and escalating issues that affect the process. Own assigned workstreams within the integrated technology transfer and PPQ plan and contribute to the start of PPQ execution. Provide timely progress, risk, and mitigation updates to the CTO and CMC leadership.
• Lead execution of technology transfer of the next-generation HSC manufacturing process into the CDMO, including authorship and execution of transfer protocols and reports, and support DOE-based process characterization to define acceptable parameter ranges ahead of process and method qualification for PPQ.
• Author and review PPQ protocols and reports, including sampling plans and acceptance criteria, and ensure the process validation package aligns with BLA timelines and regulatory expectations.
• Provide a weekly dashboard tracking manufacturing success rates and any non-conforming product issues against industry benchmarks.
• Contribute process and manufacturing content to BLA CMC sections (process description, process validation, and comparability), and support pre-license inspection readiness at the CDMO.
• Provide floor coverage across the full manufacturing sequence, from cell selection and cryopreservation through gene correction, culture, and final harvest and formulation. Verify critical process parameters and reagent formulations at the bench during execution and escalate departures from the batch record in real time.
• Review batch data and provide technical input to CDMO-authored master and executed batch records, deviations, investigations, and change controls, including assessing impact on comparability and the validated state. Coordinate change control between Kamau and the CDMO.
• Partner with Process Development and Analytical Development so the transferred process and assays meet the same acceptance criteria on both sides, and support closed-system conversion, automation, and commercial-readiness elements of the process.
• Track manufacturing success and non-conforming product rates against industry benchmarks and drive the process and oversight changes that improve them. Support trending and statistical process control that carries from PPQ into commercial manufacturing.
• Partner with Supply Chain and Process Development on bill-of-materials, critical-material supply, and cost-per-run reduction without compromising process control.
• Build effective working relationships with CDMO MSAT, Manufacturing, and Quality counterparts, using consistent on-site presence to ensure Kamau’s smooth collaboration with CDMO operations and scheduling. Track shared commitments and timelines and raise risks early for prompt joint resolution. Support campaign readiness, manufacturing slot scheduling, and capacity planning, and contribute process risk assessments (FMEA) while maintaining compliance with safety, quality standards, and company SOPs.
• Collaborate closely with the broader MSAT team and contribute to templates, standard work, and lessons learned from the transfer so that the process and ways of working scale.

Required Qualifications

• BS in chemical, biological, or process engineering (or a related life-science field) with 8+ years of hands-on MSAT, technology transfer, or process validation experience in cell or gene therapy, or an MS/PhD with 6+ years; an advanced degree is considered in lieu of some experience.
• Direct experience leading or co-leading technology transfer of a GMP process into a CDMO/CMO, and authoring and executing PPQ protocols and reports, ideally for a cell or gene therapy product heading toward licensure.
• Working knowledge of closed-system, ex vivo HSC or other primary-cell process engineering, including process characterization and control strategy concepts (CPPs, CQAs, design space).
• Hands-on familiarity with closed-system cell processing equipment (cell selection, electroporation, counterflow centrifugation, closed culture vessels, controlled-rate freezing and cryogenic storage, automated cell counting, sterile welding and sealing) and strong aseptic technique.
• Ability to work independently from day one in a startup environment, with minimal onboarding, while collaborating effectively with lead and cross-functional partners.
• Comfort working on-site at a partner manufacturing facility for extended periods during campaigns, including occasional non-standard hours.

Preferred Qualifications

• Prior experience as a technical lead or person-in-plant for a PPQ campaign at a CDMO, or prior exposure to a BLA or other commercial filing for a cell or gene therapy.
• Working knowledge of the analytical touchpoints that gate a run (cell enumeration and viability, potency, and safety testing), sufficient to interpret in-process results and judge run impact.
• Experience contributing to a BLA, MAA, or equivalent filing (CMC process description and process validation sections) or supporting pre-approval inspection readiness.
• Familiarity with gene-editing critical components and their handling constraints, including nuclease, guide RNA, and viral vector, along with cold-chain and stability limitations.
• Familiarity with statistical process control, design of experiments, process capability analysis, and trending of manufacturing performance data.
• Strong cross-functional communication skills, with the presence to drive alignment between Kamau and CDMO teams and hold a partner to commitments.

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 $150,000–$215,000 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 periodic travel within the US to CDMOs to support project demands. This role is performed in laboratory and GMP manufacturing environments and requires the ability to gown and work in classified cleanroom space for extended periods with required personal protective equipment, stand for extended periods during manufacturing operations, handle cryogenic materials with appropriate protection, 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.