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Associate Director/Director, Patient Operations

1 month ago

Emeryville, United States Kyverna Therapeutics Full time

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 Associate Director, Patient Operations - Apheresis Network Management 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 Associate Director, Patient Operations will be responsible for onboarding and managing a network of Apheresis Centers for Kyverna's autologous cell therapies and for sourcing and procuring cell sources for Kyverna's allogeneic cell therapies. This position will work with third party organizations currently involved in the management of the apheresis network to ensure consistent standards and requirements are implemented consistently and will ensure international requirements are incorporated into the network management process. In addition, they will also be responsible for maintaining the Chain of Identity and Chain of Custody throughout the vein-to-vein supply chain for Kyverna's cell therapies.

Responsibilities:

    • Manage the network of cell collection facilities for Kyverna including sourcing, verification of capabilities, and monitoring performance.
    • Manage, oversee, and evaluate performance of third party organizations involved in apheresis network management.
    • Scout and support sourcing of collection centers internationally.
    • Manage the on-boarding and continued performance of the collection centers according to program plans and strategy.
    • In close collaboration with Clinical Operations and Technical Operations, define the requirements for cells as starting materials for Kyverna Pipeline programs.
    • Communicate apheresis centers on-boarding status to internal teams and develop and execute mitigation plans for delayed timelines as requested.
    • In collaboration with the Quality organization, qualify the collection centers and monitor on-going performance.
    • Create, administer, and update the Apheresis manual and any other standards and procedures associated with cell collection, including cryopreservation and labeling as necessary.
    • Ensure collection centers carry the right accreditation and can comply with Kyverna requirements for COI/COC identifiers.
    • Create and maintain forms and labels associated with the cell collection and the COI/COC process.
    • Perform technical site assessments and train collection center staff on Kyverna collection requirements, as needed.
    • Provide Quality Systems support through management of investigations and impact assessments for any deviations associated with cell collection centers.
    • Represent the department on cross-functional project teams, as requested.
    • Ensure compliance with all applicable regulations and standards related to use of Human Blood and Tissue Products for use in Pharmaceutical Products.
    • Author and implement needed SOPs that relate to Human Blood cells as starting materials.
    • Actively engage in and contribute to all operational responsibilities related to the compliant collection and sourcing of Human Cells as Starting Materials. This includes activities such as Change Control assessments, participation in collection center audits and training, input into manuals and other documents related to the operation of the sites and clinical programs.
    • Provide input or draft relevant sections of global regulatory submissions and RFIs. Act as subject matter expert on topics related to Human Cells as Starting Materials.
    • Provide "user" type requirements for digital systems that support chain of identity and chain of custody for the in-coming and out-going cells and cell products.
    • Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the lifecycle of autologous cell therapies.
    • Provide review and approval of training materials, internal and external procedures, risk assessments, and readiness documentation in support of Apheresis Network onboarding and maintenance.
    • Source and procure cell sources for allogeneic cell therapy production.
    • Collaborate with suppliers and vendors to negotiate contracts and agreements.
    • Develop and maintain a cell source inventory management system.
    • Monitor and evaluate the quality of cell sources to ensure their suitability for use in allogeneic cell therapy production.
    • Ensure the secure storage and transportation of cell sources.
    • Manage cell source documentation, including quality control records, shipment records, and batch records.
    • Coordinate vein to vein supply chain within the US and ex-US.
    • Support other goals and deliverables as required.
Requirements:
    • Bachelor's Degree in life sciences field with minimum 10 years of experience in a regulated environment either hospital or pharmaceutical/biotech or apheresis and/or cell therapy operations management.
    • Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs essential.
    • Experience working in a regulated environment (cGMP/GCP/GTP) preferred.
    • Strong knowledge of applicable regulations and standards related to Cell Therapies, Cell Collection, and Donor Requirements.
    • Independently motivated, detail oriented and good problem-solving ability.
    • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
    • Domestic and international travel required, approximately 25% (including travel to apheresis centers and internal business meeting, as needed).
    • Experience working with critical raw material suppliers or contract manufacturing organizations.
    • Good knowledge of international standards for cell collection and donor requirements.
    • Experience with FACT/ JACIE and ISBT accreditation procedures.
    • Excellent verbal, written and presentation skills and able to communicate effectively with all levels of management.
    • 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.
    • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
    • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
    • Self-starter, works effectively in teams.


The salary range for this position is $160,000 USD to $200,000 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.

(Position is commensurate with the experience of the successful candidate.)

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