Sr Manager, Quality Control
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Sr Manager, Quality Control
Reports to: Director, Quality Control
Location: East Coast Remote
The Senior Manager will be responsible for providing sponsor oversight of CMO QC labs in support of clinical manufacturing, establishment of internal QC processes, and maintenance of the control strategy for investigational products.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Sr Manager, Quality Control
Reports to: Director, Quality Control
Location: East Coast Remote
The Senior Manager will be responsible for providing sponsor oversight of CMO QC labs in support of clinical manufacturing, establishment of internal QC processes, and maintenance of the control strategy for investigational products.
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.
The National salary range for this position is $155K to $175K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.