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
Kyverna is recruiting a Senior Manager, Quality Assurance 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 humility, elevate each other, and stay true to why. The Senior Manager will be responsible for the effective Quality oversight of the Contract Manufacturing Organizations (CMO) partnerships for investigational product release in support of clinical trials, and ensuring CMO compliance with current Good Manufacturing Practices (GMP).
Responsibilities
- Perform batch record review and lot release of investigational product manufactured at CMO partners.
- Perform QA/client review and approval for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.
- On-site oversight of CMO operations as needed to support the programs
- Liaise with Supply Chain to ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sites
- Support Manufacturing to develop and monitor key performance indicators to ensure effective oversight of CMO and contract/external laboratories.
- Draft, review, maintain, and execute against Quality Agreements with Supplier/CMO network.
- Lead and drive “right the first time” performance with CMOs to ensure clinical program expectations are met.
- Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
- Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
- Other duties as assigned by manager.
Requirements
- Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology
- 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell therapies preferred.
- Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs
- Demonstrated ability to manage multiple complex relationships within a CMO network
- Experience with electronic Quality Management Systems
- Experience in conducting or hosting Quality and/or Health Authority audits.
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Ability to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.
- Must be willing to travel up to ~50% of time, depending on manufacturing schedule.
- Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills
- Strategic thinking and high emotional intelligence
- Manage and advance multiple projects simultaneously and dynamically reprioritize as needed
- Demonstrated capacity to think creatively when addressing complex situations
- Ability to communicate effectively with Kyverna Leadership, clinical, and development scientists, and with external business partners and Regulatory Authorities.
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
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Last updated on Sep 24, 2024