Director, Manufacturing Sciences and Technology (MSAT)
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
The role of Director, Manufacturing Sciences and Technology (MSAT), reports to the Senior Vice President, Manufacturing, Sourcing and Supply within the Technical Operations organization at Kyverna. This leadership role will provide technical oversight for core MSAT functions, including CDMO technical support, technology transfer, process monitoring, process validation, as well as regulatory submission authoring and review for cell therapy drug product and lentiviral vector manufacturing processes.
This role will serve as the global technical SME for clinical and commercial Drug Product and Vector manufacturing activities. This role is responsible for implementing the process monitoring and process validation programs required to support commercialization of a CAR T drug product. This includes creation of validation standards, qualification strategy, continuous process verification program, as well as providing technical assessment for proposed process life-cycle changes. The Director MSAT will serve as a point of contact for manufacturing sites and will work with the sites to provide oversight of validation activities, manufacturing technical support, collaboration on process data management, and provide input on proposed process improvements. This role will also work across the broader Technical Operations organization to ensure alignment of key focus areas and priorities, develop strategic vision for the group, as well as hire and develop staff members in the organization.
Title: Director, MSAT
Location: Emeryville, CA
Reports to: SVP, Manufacturing
Responsibilities:
- Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry best practices for cell therapy.
- Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
- Lead, develop and implement master validation plans for process, equipment, and facilities, in collaboration with the validation and technical SME network and contract manufacturing sites.
- Develop and guide process validation, qualification and process monitoring strategies framework.
- Provide technical support to CDMO for investigations and work with the team to implement robust and compliant process data capture methods for process monitoring.
- Author and review appropriate CMC sections for regulatory submissions.
- Work with process development and analytical development to ensure early pipeline assets have a robust process enabling tech transfer and future validation requirements.
- Define strategy for execution of process performance qualification (PPQ) and product life cycle management.
- Lead establishment of drug product manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data
- Troubleshoot process issues working with other department of the organization
- Work closely with personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
- Lead and support a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
- Other duties as assigned
Requirements
- BS / MS / PhD in Chemical Engineering or Life Science with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.
- 2-3 years of experience in cell therapy process development and or manufacturing.
- Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development. At least 10 years of direct experience in GMP environment is necessary.
- Demonstrated skill to lead complex technical organizations with global scope and to build people, processes, and technology in a growing organization.
- Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent.
- Excellent communication skills to include the ability to strategically influence the direction of the company in the scope areas mentioned above.
- Experience as a technical expert in regulatory inspections and experience with interpretation and application of guidelines and regulations.
- Experience with Quality Management System.
- Prior experience in viral vector space is desirable
- Sound scientific background of process validation principles and statistics
- Sound understanding of equipment/system design, validation, quality systems
- Ability to drive project forward with cross functional collaboration
- Understand upstream and downstream processes to support Viral Vector or Biologics manufacturing
- Experience in technical investigations
- Ability to analyze and resolve technical issues
- Analyzing, interpreting, compiling data, logical conclusions, recommendations & decision making
- Naturally interested in strong documentation practices and detail oriented
- Excellent project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment
- Experience in cell therapy process development and manufacturing required.
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