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.
Reporting to the Head of External Manufacturing and Supply, this role will be responsible for successful execution of manufacturing operation activities at Kyverna’s Contract Manufacturing Organizations (CMOs) within remit.
Responsibilities
- Oversee CMOs execution and performance, conducting regular monitoring and gathering data to enable robust Supplier Relationship Management (metrics, KPIs). Provide tactical support and oversight with CMOs and strategic suppliers to ensure overall program and company deliverables are achieved.
- Collaborate with Quality to ensure GMP practices are followed by the CMOs and implement appropriate controls and liaison for Quality release.
- Work closely with CMOs and internal Quality and Technical teams to complete investigations and deviations. Support root cause analysis and product impact assessments for investigations resulting from deviations and OOS events. Act as the key liaison to facilitate periodic CAPA effectiveness reviews at the CMOs.
- Work closely with the Quality Compliance and Supplier Quality function to establish the audit strategy for Auditing and Supplier Performance monitoring and support technical site audits, including preparation for regulatory inspections.
- Engage internal and external stakeholders for change management, issue resolution and adherence to agreed-upon deliverables in a timely manner.
- Develop and implement Person-in-Plant program including activities, schedule and needed assessments at the CMOs. Manage PIP schedule to ensure adequate coverage and create and monitor reports.
- Act as technical Change Control facilitator, ensuring all required assessments are captured for the changes that originate from the CMOs or impact the CMOs. Ensures all scheduled activities occur as planned and all implementation actions are coordinated to ensure robust supply of product to patients.
- Use operational excellence mind-set and tools to review processes, procedures, and documentation to maintain simplicity, accuracy and robustness in the operational approach.
- While creating and improving documentation, process flows and internal business processes, work proactively with internal and external stakeholders to evaluate business needs and collaborate with and execute on projects as needed to support Manufacturing and Supply Chain. Processes relate to interfaces and coordination between Kyverna and its external CMOs, interfaces with internal quality and supply chain to support improvements in Vein to Vein time, supporting regulatory filings and continuous improvement. Manage and execute all associated change controls as required.
- Collaborate with program teams, execute and support program goals, including document revision and process definition.
- Evaluate capabilities and industry best practices to identify new opportunities for optimization and innovation at the CMOs.
- Ensure the creation and development of an operations playbook of dashboards, metrics blueprints reports, and tools to help monitor and drive performance of CMOs and improve operational efficiency and execution.
- Building on industry standard benchmarking performance insights but tailoring to the needs of Kyverna, it’s products and the emerging field of Cell Therapy, implement tracking, analysis, and solutions to ensure operational excellence across key Suppliers / CMOs, including but not limited to, ensuring metrics (e.g., KPIs/KQIs/KRIs) are used to monitor vendor performance.
- Lead interactions with internal and external partners by developing agendas, setting priorities for discussions, capturing meetings minutes, and tracking action items across the governance model.
- Implement and monitor activities of partnerships in collaboration with internal functional leadership teams.
- Drive and support teams in resolution of conflicts and issue triage with CMOs.
- Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
- Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results.
- Support business development due diligence projects as needed in order to support analysis and assessment of external opportunities.
- Travel as required to support PIP activity at various manufacturing CMOs up to 50% of the time.
Requirements
- Degree (Bachelors or higher) or equivalent experience in life sciences, Biochemistry, Chemical Engineering, Biotechnology.
- 8+ years of pharmaceutical manufacturing, technology transfer & process development experience with at least 2 years experience in the field of cell therapies.
- Expertise with cGMP manufacturing as well as regulatory regulations and requirements for biopharmaceutical products and ATMPs.
- Demonstrated ability to manage multiple complex relationships with CMO network.
- Knowledge and experience in managing manufacturing operations for clinical trial products and aseptic processes, with an emphasis on cell therapies.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
- Strategic thinking and high emotional intelligence.
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment.
- Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
- Demonstrated success in leading high performing teams.
- Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.
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Last updated on Sep 27, 2024