Director, Process Development

Kyverna Therapeutics • Emeryville, CA, USA • 1m ago

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

Kyverna is seeking a Director, Process Development in its Technical Development organization. The Director, Process Development, will be focused on developing robust processes for the expansion of genetically modified T-cells suitable for administration to patients in our clinical studies. The role will also provide technical input to processes at Third Party CMOs and to assess the risks and potential opportunities associated with partnerships important to Kyverna.

Title: Director, Process Development

Reporting to: Executive Director, Head of Technical Development

Location: Emeryville, CA (Hybrid – twice a week)

Responsibilities

Provide process development leadership for new product development, technology transfer and support for GMP manufacturing for engineered T cell therapy products.
Plan and oversee activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies, technical assessment and approval for engineering and process changes, and oversee documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
Lead a process development team of scientists and engineers through strong mentorship, influence, teamwork, and a get it done mentality.
Author and review technical protocols and reports, batch records, change controls, investigation reports, and corrective and preventative actions.
Author and review CMC sections of regulatory documents in support of both clinical trial (IND/IMPD) and commercial therapeutic applications (BLA/MAA).
Develop and implement plans and studies necessary to incorporate new technologies to enable the mission and needs of pipeline products.
Plan and oversee execution of studies supporting process development, process characterization, and life cycle change management to ensure on time and in full delivery supporting company development plans and timelines.
Serve as the accountable technical interface between Kyverna Process Development and the process development and manufacturing departments of CDMO partners to manage process development and process characterization activities supporting the advancement of engineered cell-based therapies in the pipeline.
Support CMC and product development teams including contributions of robust data analysis, solid cell process development and implementation, and incorporation of the manufacturing and development strategy within CMC functions.
Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell Therapy Development operations and products.
Establish and ensure strong relationships with key partners in Analytica Development, Manufacturing, Quality, Clinical and Regulatory.

Requirements

Master’s degree in cell biology, Immunology, Molecular Biology, Chemical Engineering, Biotechnology or equivalent. PhD is preferred.
10+ years of pharmaceutical manufacturing, technology transfer & process development experience.
Proven expertise in CAR-T (or other ex-vivo gene modified) cell therapy process development, process characterization, tech transfer and comparability assessment.
Established track record of success supporting early and late-stage CMC and clinical product development teams.
Expertise with cGMP manufacturing as well as regulatory regulations and requirements for pharmaceuticals and devices.
Excellent interpersonal, verbal and written communication skills.
Ability to function efficiently and independently in a changing environment.
Ability to foster a strong team-first environment to enable delivery of company goals.
Demonstrated success in leading high performing development teams and growing talent.
Demonstrated capacity to think creatively when addressing complex situations.
Ability to collaborate and communicate effectively with Kyverna Leadership, Analytical Development, Manufacturing, Quality, Clinical and Regulatory teams and with external business partners and Regulatory Authorities.

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

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