Senior Manager, MSAT

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated

Kyverna is recruiting a highly motivated Senior Manager, MSAT in its Technical Operations organization to help advance its mission to free patients from the siege of autoimmune disease. 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. The successful candidate will join the Process Development – Cell Therapy Group and contribute to the development of genetically modified T cell manufacturing processes and will be responsible for managing Tech Transfer of our cell processes to external organizations partnering with Kyverna in manufacturing and process development.

Responsibilities

• Responsible for Technical Transfer from Process Development to CDMOs.
• Define the process for and execute the cGMP manufacturing process transfer to an external contract development and manufacturing organization (CDMO).
• Ensure the manufacturing process meets all regulatory and scientific requirements as appropriate for clinical manufacturing according to regional regulatory requirements.
• Implement, monitor and manage the technical capability of the manufacturing process, including establishing, monitoring, and refining critical process parameters to consistently meet key quality attributes through all stages of development.
• Serve as technical interface between external and internal groups to lead troubleshooting and process improvement efforts.
• Implement the Process Monitoring Program to establish and track process performance across the network.
• Provide subject matter expert input into process design, comparability, and change control studies and systems.
• Contributes information related to the process for regulatory applications and amendments.
• In addition, the candidate will work closely with project management and other technical functions to ensure milestone timelines and deliverables are consistently met.
• Other duties as assigned.

Requirements

• B.S. or M.S degree in biochemical engineering, chemical engineering, molecular biology/biochemistry, or related field
• 8+ years of experience in a cGMP environment including experience with cGMP manufacturing, tech transfers, and regulatory submissions
• Experience in development of cell therapy is required, including a working knowledge of enrichment/ isolation, gene editing, cultivation, and harvest/cryopreservation methods as well as working knowledge of corresponding analytical and QC methods
• Robust knowledge of both domestic and international chemistry, manufacturing, and controls (CMC) requirements associated with advanced cell therapy manufacturing
• Prior experience managing projects and timelines, leading meetings, collaborating, and communicating with external parties
• Excellent technical writing skills with prior experience authoring protocols Standard Operating Procedures (SOPs), Master Batch Records (MBRs), deviation investigations, change controls, engineering and qualification reports, as well as competency reviewing and approving these documents
• Proficiency in basic statistical analysis
• Enjoys working as a team with excellent communication and people skills
• Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Able to effectively achieve targets and lead activities in a highly matrixed environment.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Position will require domestic and international travel ( 25% time)

The salary range for candidates residing in California for this position is $137,000 USD to $162,500 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 geographic location, 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.

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets