Associate Director, External Manufacturing and Supply

Responsibilities

• Oversee CDMO execution and performance, conducting regular monitoring and gathering data to enable robust Supplier Relationship Management (metrics, KPIs). Provide tactical support and oversight with CDMOs and strategic suppliers to ensure overall program and company deliverables are achieved.
• Collaborate with Quality to ensure GMP practices are followed by the CDMOs and implement appropriate controls and liaison for Quality release.
• Work closely with CDMOs 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.
• 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.
• Manage Person-in-Plant program including activities, schedule and needed assessments at the CDMOs. Manage PIP schedule to ensure adequate coverage.
• Act as Change Control facilitator, when appropriate, ensuring all required assessments are captured for the changes that originate from the CDMOs or impact the CDMOs. 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. Processes relate to interfaces and coordination between Kyverna and its external CDMOs, interfaces with internal quality and supply chain to support improvements in turnaround time (TAT), 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 CDMOs.
• Manage the operations playbook of dashboards, metrics blueprints reports, and tools to help monitor and drive performance of CDMOs 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 / CDMOs, including but not limited to, ensuring metrics 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 CDMOs.
• 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 to support analysis and assessment of external opportunities.
• Travel as required to support activity at various manufacturing CDMOs up to 25% 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 year’s 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 within a CDMO network.
• Knowledge and experience in managing manufacturing operations for clinical trial and/or commercial products, with an emphasis on cell therapies.
• Ability to think critically and demonstrate 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, MSAT, Supply Chain, Regulatory, Quality, Regulatory, and with external business partners and Regulatory Authorities.