Kyverna Therapeutics
Associate Director, External Manufacturing and Supply
Emeryville, CA · Director
Sponsorship not specified$160k-$180kDetected 6 days ago
Business DevelopmentAuditingSupply ChainGMPLeadershipCommunicationCollaborationProblem Solving
About the role
- Join us at the forefront of cell therapy innovation and help redefine what's possible.
- Oversee CDMO execution and performance, conducting regular monitoring and gathering data to enable robust Supplier Relationship Management (metrics, KPIs).
- The national salary range for this position is $160K to $180K USD annually.
Responsibilities
- 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.
- Use operational excellence mind-set and tools to review processes, procedures, and documentation to maintain simplicity, accuracy and robustness in the operational approach.
- Collaborate with program teams, execute and support program goals, including document revision and process definition.
- 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.
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.
- 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.
- Ability to function efficiently and independently in a changing environment.
- 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.
- Manage and execute all associated change controls as required.
- Travel as required to support activity at various manufacturing CDMOs up to 25% of the time.
Compensation
- The national salary range for this position is $160K to $180K USD annually.
Benefits
- Manage PIP schedule to ensure adequate coverage.
Company info
- Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease.
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This listing is sourced directly from Kyverna Therapeutics's careers page and normalized into a canonical job model.