Senior Manager - Patient Operations

May 18

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Kyverna Therapeutics

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cell therapy • autoimmune • lupus

51 - 200

💰 $85M Series B on 2022-01

Description

Requirements

• Bachelor’s Degree in life sciences field with minimum 6+ 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 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.

Benefits

• 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. • Administer creation and updating of 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. • Support authoring and implementation of SOPs that relate to Human Blood cells as starting materials, as needed. • 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. • 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 EU. • Support other goals and deliverables as required.