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Principal MSAT Engineer na Kyverna

Kyverna · Emeryville, Estados Unidos Da América · Hybrid

$160,000.00  -  $190,000.00

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Kyverna is seeking a highly motivated Principal MSAT Engineer. This position will play a pivotal role in supporting/leading Technology Transfer (TT) activities, including training internal and external manufacturing and MSAT teams. This role will also drive process improvements for our lead assets, with support from PD. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why. 

Title: Principal MSAT Engineer
Reporting to: Director MSAT
Work Location: Emeryville, CA (Hybrid twice a week)


Responsibilities
  • Lead all aspects of Technology Transfer (TT), including training internal and external manufacturing and MSAT teams.
  • Drive process optimization and continuous improvement initiatives for lead assets in collaboration with Process Development (PD).
  • Serve as the MSAT Lead supporting CDMO facilities for Asset 1.
  • Provide expertise in process validation, process performance qualification (PPQ), and commercial product launch readiness.
  • Prepare, present, and communicate technical findings, progress, and recommendations to leadership and cross-functional teams.
  • Lead or support product impact assessments, deviation investigations, trending analyses, CAPAs, and change controls.
  • Monitor, interpret, and analyze manufacturing data to identify trends, drive process improvements, and resolve technical issues.
  • Contribute to risk assessments, including process FMEAs, to inform validation strategies and new product introductions at CDMOs.
  • Lead systematic, data-driven investigations using DMAIC methodology to determine root cause and implement corrective measures, including knowledge of critical equipment.
  • Participate in the evaluation, adoption, and implementation of new technologies and process automation.
  • Author or support regulatory submissions and provide audit readiness and on-site audit support (internal and CDMO).
  • Identify, assess, and communicate risks associated with processes, technologies, and methods, recommending mitigation strategies.


    • Qualifications
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred.
  • 8+ years of biotech/pharma experience, ideally in cGMP manufacturing or manufacturing support.
  • Strong knowledge of cGMP regulations, quality systems, and compliance requirements.
  • Expertise in biologics manufacturing, aseptic processing, cell therapy, and process development.
  • Experience with process validation, PPQ, and late-stage/commercial manufacturing.
  • Proficiency with statistical tools (e.g., JMP, Minitab) and data management systems.
  • Familiarity with Lean Six Sigma principles; certification a plus.
  • Excellent problem-solving, communication, and collaboration skills.
  • Adaptable, self-motivated, and able to work independently in a fast-paced environment.


    • The salary range for this position is from $160,000 to $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
     
     
     
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