Sonoma BioTherapeutics
Director, Quality Control - Cell Therapy
Sonoma BioTherapeutics, Seattle, Washington, us, 98127
About Sonoma Biotherapeutics:Sonoma Biotherapeutics is a South San Francisco and Seattle-based clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. Sonoma Bio has initiated two Phase 1 studies to evaluate the safety and proof-of-mechanism of the company’s lead Treg cell therapy candidate, SBT-77-7101, in patients with rheumatoid arthritis and hidradenitis suppurativa. The company has a partnership with Regeneron to discover, develop and commercialize novel regulatory T cell therapies. More information at
www.sonomabio.com .Position SummaryThe Director of QC will be responsible for assisting in qualifying / validating methods to support phase-appropriate development and regulatory deliverables. This candidate will also be responsible for the method transfer to internal or external QC labs. The candidate will also serve as the in-house expert providing requirements for and ownership of cGMP in-process, release, and stability methods to enable optimal quality control testing of clinical CAR-Treg cell therapy starting materials, drug substance and final drug product. The candidate will achieve these objectives by collaborating closely with Sonoma Biotherapeutic’s technical functions, CDMOs (Contract Development and Manufacturing Organization), and the program level cross-functional team.Our ideal candidate is a self-motivated individual with a passion for improving current manufacturing practices for cell therapies. Experience in immune cell phenotyping, cell-based assays and tech-transfer are important requirements.Candidates should enjoy working in a collaborative, fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.Key Responsibilities
Work cross-functionally with process development and analytical development, regulatory affairs, quality assurance and external CRO partners to provide analytical support, training and troubleshooting.Data analysis, interpretation, and presentations, authoring SOPs, qualification, and validation reports.Exercise sound technical judgment to solve a wide range of complex scientific problems. Provide scientific evaluation of novel experiments and make recommendations to management.Communicate and present complex scientific findings and recommendations in team, external partners, departmental, functional, and international meetings.Roles and Responsibilities – QC
Provide requirements for and own cGMP in-process, release, and stability methods/Protocols to enable optimal Quality Control testing of clinical CAR-Treg cell therapy starting materials and final drug product.Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function.Draft and or support finalization, and provide QC approval of SOPs, protocols, method validations, stability studies and reports, as well as analytical reports.Draft and or support finalization, and provide QC approval of sample collection procedures, storage, and transmission specifications for cGMP protocols, system suitability controls, assay raw material specifications, and all cGMP test methods.Manage or provide oversight of CAPAS, Change Controls, and investigation of Out of Specification (OOS), Out of Tolerance (OOT), and any anomalous results.Implement and manage QC metric reporting to monitor key attributes, implementing corrective and preventive actions as needed.Apply statistical analysis methods to review QC data/trends and determine if any corrective actions are needed.Provide input into CMC teams on topics of analytical importance and impact.Perform data verification for all analytical sections of IND/BLA and other regulatory documents.Build and maintain strong collaborative relationships with CDMO and CTO partners, and hold them accountable to Sonoma Biotherapeutics quality standards as per the Quality Agreements.Roles and Responsibilities - Analytical
Partner with the Analytical Development team to investigate and implement new technologies and QC friendly molecular platforms within Cell Therapy CMC strategies to enable and deliver IND and BLA filings.Responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs.Mentor and develop staff at all levels in the organization.Responsible for establishing operating budgets and managing expenses within those budgets.Identification and selection of contract testing organizations for performing development as well as product release testing.Oversight of technical transfer between laboratories, qualification/validation of assays at a CDMO and QC activities for material release.Identification and communication of risks in assay performance and their mitigation.Qualifications and Education Requirements:
Demonstrated depth of knowledge and experience in analytics for Cell Therapy, (ideally human cells/cell lines including PBMC, CAR-T cells, iPSC, etc.)Experience in assay qualification and validation.Demonstrated technical leadership in the Quality Control function.Experience engaging and managing contract organizations.Experience in writing protocols / reports / SOPs and scientific presentations.Experience ensuring GMP compliance for the company; ability to collaborate with QA on setting strategy for investigations and CAPAs, and ensuring follow up.Experience in a cGMP QC laboratory environment within a cell or gene therapy QC organization.Technical expertise in drafting and reviewing CAPAS, Change controls, and investigation of OOS, OOT, and anomalous results.Strong understanding of technical transfer and the associated cGMP requirements.Proven ability to provide analytical expertise to programs/project teams for clinical studies.Experience contributing to IND and or BLA submissions (i.e. M3 section generation).Ability to identify gaps in technology and operational systems and solve complex and diverse operational and scientific problems requiring original thinking and deductive reasoning.Ability to function in a constantly evolving environment and balance multiple priorities simultaneously.Ability to travel up to 25%.Preferred Skills:
Experience with assay design, qualification, and validation per ICH / USP.Knowledge of cellular immunology, specifically regulatory T cells.Understand how GMP requirements are applied to practice over QC release and stability.Knowledge of FDA / ICH regulatory guidelines as applied to the testing of biological molecules as well as cell and gene therapies.Ability to work in a fast-moving dynamic small company environment.Consistent track record in making key decisions.Outstanding written and oral communication skills are essential.Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management.High sense of integrity and professionalism and the ability to work well in a cross functional team environment.
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www.sonomabio.com .Position SummaryThe Director of QC will be responsible for assisting in qualifying / validating methods to support phase-appropriate development and regulatory deliverables. This candidate will also be responsible for the method transfer to internal or external QC labs. The candidate will also serve as the in-house expert providing requirements for and ownership of cGMP in-process, release, and stability methods to enable optimal quality control testing of clinical CAR-Treg cell therapy starting materials, drug substance and final drug product. The candidate will achieve these objectives by collaborating closely with Sonoma Biotherapeutic’s technical functions, CDMOs (Contract Development and Manufacturing Organization), and the program level cross-functional team.Our ideal candidate is a self-motivated individual with a passion for improving current manufacturing practices for cell therapies. Experience in immune cell phenotyping, cell-based assays and tech-transfer are important requirements.Candidates should enjoy working in a collaborative, fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.Key Responsibilities
Work cross-functionally with process development and analytical development, regulatory affairs, quality assurance and external CRO partners to provide analytical support, training and troubleshooting.Data analysis, interpretation, and presentations, authoring SOPs, qualification, and validation reports.Exercise sound technical judgment to solve a wide range of complex scientific problems. Provide scientific evaluation of novel experiments and make recommendations to management.Communicate and present complex scientific findings and recommendations in team, external partners, departmental, functional, and international meetings.Roles and Responsibilities – QC
Provide requirements for and own cGMP in-process, release, and stability methods/Protocols to enable optimal Quality Control testing of clinical CAR-Treg cell therapy starting materials and final drug product.Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function.Draft and or support finalization, and provide QC approval of SOPs, protocols, method validations, stability studies and reports, as well as analytical reports.Draft and or support finalization, and provide QC approval of sample collection procedures, storage, and transmission specifications for cGMP protocols, system suitability controls, assay raw material specifications, and all cGMP test methods.Manage or provide oversight of CAPAS, Change Controls, and investigation of Out of Specification (OOS), Out of Tolerance (OOT), and any anomalous results.Implement and manage QC metric reporting to monitor key attributes, implementing corrective and preventive actions as needed.Apply statistical analysis methods to review QC data/trends and determine if any corrective actions are needed.Provide input into CMC teams on topics of analytical importance and impact.Perform data verification for all analytical sections of IND/BLA and other regulatory documents.Build and maintain strong collaborative relationships with CDMO and CTO partners, and hold them accountable to Sonoma Biotherapeutics quality standards as per the Quality Agreements.Roles and Responsibilities - Analytical
Partner with the Analytical Development team to investigate and implement new technologies and QC friendly molecular platforms within Cell Therapy CMC strategies to enable and deliver IND and BLA filings.Responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs.Mentor and develop staff at all levels in the organization.Responsible for establishing operating budgets and managing expenses within those budgets.Identification and selection of contract testing organizations for performing development as well as product release testing.Oversight of technical transfer between laboratories, qualification/validation of assays at a CDMO and QC activities for material release.Identification and communication of risks in assay performance and their mitigation.Qualifications and Education Requirements:
Demonstrated depth of knowledge and experience in analytics for Cell Therapy, (ideally human cells/cell lines including PBMC, CAR-T cells, iPSC, etc.)Experience in assay qualification and validation.Demonstrated technical leadership in the Quality Control function.Experience engaging and managing contract organizations.Experience in writing protocols / reports / SOPs and scientific presentations.Experience ensuring GMP compliance for the company; ability to collaborate with QA on setting strategy for investigations and CAPAs, and ensuring follow up.Experience in a cGMP QC laboratory environment within a cell or gene therapy QC organization.Technical expertise in drafting and reviewing CAPAS, Change controls, and investigation of OOS, OOT, and anomalous results.Strong understanding of technical transfer and the associated cGMP requirements.Proven ability to provide analytical expertise to programs/project teams for clinical studies.Experience contributing to IND and or BLA submissions (i.e. M3 section generation).Ability to identify gaps in technology and operational systems and solve complex and diverse operational and scientific problems requiring original thinking and deductive reasoning.Ability to function in a constantly evolving environment and balance multiple priorities simultaneously.Ability to travel up to 25%.Preferred Skills:
Experience with assay design, qualification, and validation per ICH / USP.Knowledge of cellular immunology, specifically regulatory T cells.Understand how GMP requirements are applied to practice over QC release and stability.Knowledge of FDA / ICH regulatory guidelines as applied to the testing of biological molecules as well as cell and gene therapies.Ability to work in a fast-moving dynamic small company environment.Consistent track record in making key decisions.Outstanding written and oral communication skills are essential.Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management.High sense of integrity and professionalism and the ability to work well in a cross functional team environment.
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