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.
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.
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.