Senior Scientist, Formulation Lead

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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 Scientist, Formulation Development 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 developing the next generation of cell therapy processes.

Responsibilities

• Develop novel methods of formulation and filling for final drug products and intermediate drug products for both allogeneic and autologous cell therapies.
• Evaluate and develop optimal formulations of in-process and final product formulation reagents to establish robust process control and optimal product recovery.
• Design and execute product stability testing to ensure products meet clinical and commercial requirements for stability and shelf life.
• Work closely with external vendors and partners to evaluate novel technologies that will enable the next generation of cell therapy products.
• Collaborate with other development and CMC functions to ensure formulated product meets clinical and dosing requirements for different phases of product development.
• Implement automation where feasible to minimize variability and increase process control.
• Characterize product formulations through the development phase and implement a continuous monitoring program to ensure product consistency and comparability.
• Serve as technical interface between external and internal groups to lead troubleshooting and process improvement efforts.
• 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

• PhD or M.S. degree in biochemistry, molecular biology, chemistry, or B.S. degree in related field with commensurate experience.
• 4+ years of experience in an industry setting, preferably including experience in a biologics or cell therapy development laboratory.
• Experience with cell formulation and cryopreservation is required.
• Working knowledge of closed systems and common formulation and filling methods is required.
• 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 may require occasional travel (<10% time).

$140,000 - $185,000 a year

The base salary range for candidates residing in California for this position is  $140,0000 - USD to $185,000 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, relevant experience, tenure, skills and abilities, geographic location, 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