Kyverna Therapeutics
Sr Manager, QA Operations
Emeryville, CA · Senior
Sponsorship not specified$160k-$180kDetected 26 days ago
Product ManagementProject ManagementGMPCommunicationProblem Solving
About the role
- Join us at the forefront of cell therapy innovation and help redefine what's possible.
- The national salary range for this position is from $160K to $180K USD annually.
Responsibilities
- Support Patient Operations in the on-boarding and continued performance of the apheresis collection centers and cell therapy labs according to program plans and strategy.
- Drive and support continuous improvement initiatives to enhance quality systems, operational efficiency, compliance, and inspection readiness.
- Lead batch release activities for clinical and commercial products, ensuring compliance with applicable regulatory requirements and internal quality standards.
- Support Qualified Person (QP) certification activities by ensuring batches meet registered specifications, regulatory requirements, and current GMP expectations.
- Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases.
Requirements
- Experience with cGMP manufacturing and GDP as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs.
- Domestic and international travel required, approximately 10% (including travel to CDMOs and/or Suppliers and internal business meeting, as needed).
- Support inspection readiness, other goals, and deliverables as required.
- Bachelors or Masters in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or other related major.
- Strong Project Management skills and ability to manage multiple projects simultaneously.
- Independently motivated, detail oriented and good problem-solving ability.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Excellent verbal, written and presentation skills and effectively communicate with all levels of management.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
- The national salary range for this position is from $160K to $180K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company's stock plan.
Nice to have
- 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell/gene therapies preferred.
Compensation
- The national salary range for this position is from $160K to $180K USD annually.
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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