- Provide Quality oversight of the international network of cell collection facilities for Kyverna including sourcing, verification of capabilities, and monitoring performance.
- Support 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/cell processing center on-boarding and qualification status to internal teams and develop and execute mitigation plans for delayed timelines as requested.
- Qualify the collection/processing centers, including maintenance of qualification criteria and scheduling/coordination/performance of audits as required.
- Ensure collection/processing centers carry the right accreditation and can comply with Kyverna requirements for COI/COC identifiers.
- Review and approve forms and labels associated with the cell collection and the COI/COC process.
- Create and maintain Quality-related agreements with cell collection centers and/or third-party organizations, as required.
- Perform site assessments for compliance with, and train collection/processing center staff on, Kyverna requirements, as needed.
- Provide Quality Systems support through review and approval of investigations and impact assessments for any deviations associated with cell collection/processing centers.
- Represent Quality Assurance 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.
- Review and approve needed SOPs and other documentation that relate to Human Blood cells as starting materials.
- 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.
- Monitor and evaluate the quality of cell sources to ensure their suitability for use in allogeneic cell therapy production.
- Support other goals and deliverables as required.
- 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) in a Quality Assurance role 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 effectively communicate 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.
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Associate Director, Patient Operations - Emeryville, CA, United States - Kyverna Therapeutics, Inc.
Description
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 Associate Director, Patient Operations – Quality Assurance 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 – QA will be responsible for onboarding and oversight of a network of Apheresis and Cell Processing Centers for Kyverna's autologous and 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:The salary range for this position is $165,000 to $180,000 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.
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
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