Senior Manager, Quality Control

🕒 July 17

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Provide sponsor oversight of CMO QC labs in support of clinical manufacturing. • Establish internal QC processes and maintain control strategy for investigational products. • Support analytical control strategies for Kyverna’s clinical products including ownership of product specifications. • Develop and maintain Kyverna’s stability program, including establishment of trend monitoring and statistical evaluation practices. • Manage Validation/Qualification of Analytical methods as needed, to support multi-phase clinical trials. • Provide subject matter expertise in the investigation of laboratory deviations, out of trend (OOT) and out of specification (OOS) events. • Maintain Kyverna’s internal Quality Control data management and review process, and Certificate of Analysis (COA) generation. • Support Manufacturing to develop and monitor key performance indicators and risk registry to ensure effective oversight of contract/external laboratories. • Ensure QC 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. • Support business development due diligence projects as needed to support analysis and assessment of internal/external laboratory capabilities. • Other duties as assigned.

🎯 Requirements

• Bachelor's degree in, 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 overseeing cell therapies contract labs preferred. • Experience with method transfer from Analytical Development to QC and to/from external labs. • Expertise with cGMP analytical requirements, including regulatory regulations and requirements for biopharmaceutical products and ATMPs. • Demonstrated ability to manage laboratory personnel in a GMP setting, including training, establishment of laboratory procedures, and stability program maintenance. • Experience in statistical evaluation of analytical trend data. • Deep knowledge and experience in various analytical methods employed for cell therapy products, including flow cytometry, molecular/PCR-based assays, cell-based potency assays, and safety testing. • Must be willing to travel periodically, as needed, no more than 25% of the time. • Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment 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 capacity to think creatively when addressing complex situations. • Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.

🏖️ Benefits

• Bonus • Benefits • Participation in Company’s stock plan