Senior Manager, Quality Control

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.
• Other duties as assigned.

Requirements

• Degree (bachelor's 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 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.