Sr Manager, QA Patient Operations Management & Supply Chain

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 Sr Manager, QA Patient Operations Management & Supply Chain in its Technical Operations organization to help advance its mission to transform the treatment of autoimmunity for the benefit of patients. 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.

Responsibilities

• In close collaboration with QA Operations, Patient (and Clinical) Operations, Manufacturing, and Supply Chain, monitor the journey of product from apheresis collection through manufacturing, release, and shipment to the clinical site.

• Track and report metrics related to product journey milestones.

• Represent QA at daily patient orchestration meetings to communicate the status of product release against targets.

• Review and approve Good Distribution Practice (GDP) SOPs, forms, and other associated documentation with the cell collection and the COI (Chain of Identity) /COC (Chain of Custody) process.

• Oversee Supply Chain vendors

• Conduct the quality review and approval of investigations and impact assessments for any deviations associated with cell collection/processing centers, or other support for QA Operations, as needed.

• Support Patient Operations in the on-boarding and continued performance of the apheresis collection centers and cell therapy labs according to program plans and strategy.

• Review and approve needed SOPs and other documentation that relate to apheresis collection, COI, and product shipment.

• Quality key user for Kyverna's Patient Orchestration IT solution.

• Support other goals and deliverables as required.

• Other duties as assigned by manager.

Requirements

• Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology

• 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell therapies and supply chain preferred.

• Experience working with an electronic Quality Management System required.

• Experience with cGMP manufacturing and GDP as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs.

• Strong Project Management skills and ability to manage multiple projects simultaneously.

• 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).

• Excellent verbal, written and presentation skills and effectively communicate with all levels of management.

• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.

$155,000 - $170,000 a year

The salary range for candidates residing in California for this position is $155,000 USD to $170,000 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 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