Associate Director, Analytical Science and Technology
Emeryville, CA
Tech Ops /
Full Time /
On-site
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Reporting to the Senior Director of Technical Analytical Development, the Associate Director of Analytical Science and Technology (AD, AS&T) is responsible for establishing the Analytical Science and Technologies group. The group will be responsible for drug product lifecycle management, data analytics, and analytical operations including the implementation of automation to development lab workflows. The AD will work closely with the Tech AD team to build the AS&T function and support the hiring of staff as appropriate. The AD, AS&T will manage the effective execution of analytical method technology transfer, troubleshooting, and validation of a range of analytical methodologies at a number of analytical contract testing sites. In addition, they will work closely as an analytical subject matter expert to support colleagues in our manufacturing, quality, and regulatory functions to define specifications, and development and management of the overall control strategy (including in-process and product characterization strategies) as the department subject matter expert in lifecycle management. This role will be responsible, in collaboration with manufacturing and quality, for data collection, verification, and analysis across the manufacturing landscape. The individual will present data-driven recommendations to cross-functional leadership teams, based on their thorough and in-depth understanding of the analytical issues involved.
Responsibilities
- Analytical Operations: Define and develop team, procedures and processes to support analytical operations, in-house testing of PD materials, and testing of materials from contract development and manufacturing organizations for process and drug product characterization as well as analytical method development.
- Data Analytics: Support and manage data analytics (collection, verification, automation, visualization) for drug product characteristics (release, characterization, in-process testing) across the portfolio.
- Life Cycle Management: Support the establishment of control strategies for lenti-viral vector and CART cells to support release and characterization testing of both autologous and allogeneic drug products.
- Work closely with Quality, Manufacturing, and Regulatory team members to ensure appropriateness of release specifications, assay controls, characterization panels and control of raw materials for the development stage of each program.
- Work closely with both internal and external subject matter experts to ensure successful analytical method technology transfer.
- Support and manage outsourced analytical methods across a global network of vendors for clinical stage lenti-viral vector and drug product manufacturing.
- Support the strategy and effectively guide and direct the execution of assay validation, transfer, optimization, and development appropriate to support clinical manufacturing.
- Work closely with Quality and Manufacturing colleagues in support of and to analyze data relating to lot release testing, in-process testing, stability testing, stability analysis, characterization, and assay qualification/validation.
- Help prepare and review CMC documentation for analytical sections of regulatory filings to multiple agencies to support Kyverna’s global regulatory strategy.
- Work with cross functional teams to meet company goals.
- Analyze and trend testing results. Prepare and present clear data-driven presentations, and propose solutions based on these data.
- Author and review clear and concise technical reports, development plans, technical protocols and other documentation.
- Other duties as assigned.
Requirements
- PhD in biochemistry, biology, immunology, genetics, or related area with at least 7 years of relevant pharmaceutical/ biotech experience, or BS/MS with a corresponding equivalent number of years of relevant experience, at least 4 of which include analysis of genetically modified cells or gene therapies.
- Experience with management of contract analytical work in CAR T or other ex-vivo cell therapeutic discipline and/or lenti-viral vector, including analytical method development, technology transfer, and validation.
- Broad experience in analytical techniques used to interrogate ex-vivo cell therapies (CART) and LVV, including but not limited to; molecular techniques (ddPCR, qPCR, NGS), flow cytometry, cell-based methods (bioassays, luciferase-based reporter systems, killing assays), imaging techniques.
- Experience establishing and managing analytical control strategies for LVV transduced cell therapies (or similar modalities) during multiple stages of the product development lifecycle.
- Experience effectively managing teams in a fast-paced high stakes environment.
- Significant experience with analytical development, method fit for purpose assessments including validation, and assay troubleshooting in advanced therapy medicines (lenti-viral vector, gene therapies, and ex-vivo cell therapies). Experience should span several or all of molecular, cytometry, immunoassay, residuals, and cell-based assay methodologies.
- A strong scientific mindset and ability to effectively interrogate data to build and communicate an understanding of assay and product behavior and to justify data-driven proposals and recommendations.
- An understanding of the cGMP requirements of analysis of ex-vivo CART cell therapies.
- Familiarity with statistical analysis and statistical process control
- Effective written and oral communication skills.
- Proven track record of effectively working with others to achieve group goals while contributing at a high level to solve problems and effectively manage time and priorities.
- Occasional travel to support vendor management activities will be expected for this position.
$170,000 - $205,000 a year
The base salary range for candidates residing in California for this position is $170,000 - $205,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, relevant experience, tenure, skills and abilities, geographic location, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
