Sr Manager, Quality Control

Responsibilities

• 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

Qualifications

• 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
• Strategic thinking and high emotional intelligence
• Excellent interpersonal, verbal, and written communication skills
• Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills
• Manage and advance multiple projects simultaneously and dynamically reprioritize as needed
• Demonstrated capacity to think creatively when addressing complex situations
• Communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities

Pay

The National salary range for this position is $155K to $175K USD annually.

Schedule

This position is also eligible for bonus, benefits, and participation in Company’s stock plan.