Kyverna - Sr Manager, Quality Control
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.
Responsibilities
• In collaboration with Analytical Development and other groups, 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.
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