Director, External Manufacturing and Supply
Emeryville, CA /
Tech Ops /
Full Time
/ On-site
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna is navigating what’s next in the synthetic biology, immunology and cell engineering to create a new class of T-cell therapies programmed to target and selectively modulate the underlying causes of autoimmunity. Join the front lines of a cell therapy revolution where scientists, industry veterans and healthcare visionaries are creating a new class of living medicines for autoimmune disease.
Kyverna is recruiting a Director, External Manufacturing and Supply in its Technical Operations organization to help advance its mission to transform the treatment of autoimmunity for the benefit of patients. 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 Director will be responsible for the effective leadership, strategic planning, and oversight of the Supplier / CMO partnerships for clinical development and lifecycle management clinical trials, optimizing strategic partnership models, driving partners’ overall performance as well as facilitating executive level governance meetings. The Director will consider the future needs of the clinical development portfolio and other considerations to maximize relationships with Suppliers / CMOs, in order to drive optimal effectiveness, value and efficiency in these relationships and overall operational excellence.
Responsibilities:
- Reporting to the Head of Manufacturing and Supply
- Maintain knowledge internationally, of CDMO capability and capacity in the Cell Therapy field and source capacity for Kyverna pipeline programs to maintain robust supply of clinical product wherever patients are located.
- MUST BE WILLING TO TRAVEL UP TO ~50% OF TIME, DEPENDING ON MANUFACTURING SCHEDULE.
- Provide subject matter expertise in negotiating terms and managing obligations with the network of CDMOs and key suppliers/service providers.
- Lead and drive the strategic partnerships for new or existing Suppliers/CMOs, and ensure proper governance, maintenance, and performance improvement.
- Orchestrate the process and systems to evaluate CMOs/Supplies’ capabilities that identify new opportunities for optimization and innovation.
- Define and implement operational Supplier / CMO oversight and governance model.
- Interprets internal stakeholder needs and collaborates with and provides guidance to Suppliers /CMOs to ensure new capabilities are developed to meet identified internal needs.
- In collaboration with program teams, define and implement optimal sourcing strategy for Kyverna portfolio, including overseeing vendor transitions, developing new sourcing models, and identifying new partners.
- Provide leadership at executive level governance meetings with CDMos and strategic suppliers to ensure consistency to charters and consistency of delivery across partners and programs.
- In collaboration with various internal departments and cross-functional teams, support contract and change order negotiations, renegotiations, including MSA, SOWs and employ methods to effectively lower overall costs while maintaining high quality and optimal speed of delivery.
- Evaluate capabilities and industry best practices to identify new opportunities for optimization and innovation in clinical development.
- Ensure the creation and development of an operations playbook of dashboards, metrics blueprints reports, and tools to help monitor and drive performance of Suppliers / 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.
- Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
- Lead interactions/chair committees with Suppliers 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 Suppliers/CMOs.
- Identify and document best practices for different partnerships to evaluate and implement with Kyverna’s Suppliers / CMOs and develop a supplier contact database.
- 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.
Requirements:
- Degree (Bachelors or higher) or equivalent experience in life sciences, Biochemistry, Chemical Engineering, Biotechnology.
- 12+ 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.
- Deep knowledge and experience in managing manufacturing and supply 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.
The base salary range for candidates residing in California for this position is $180,000 USD to $200,000 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, relevant experience, tenure, skills and abilities, geographic location, 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
