Jade Biosciences
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Pay found in job post Retrieved from the description.
Base pay range $210,000.00/yr - $235,000.00/yr
About Jade Biosciences Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long‑term kidney function. A Phase 1 healthy‑volunteer study of JADE101 is ongoing, with interim, biomarker‑rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development.
Role Overview The Director, Quality Control will lead critical Quality Control activities to support Jade’s product pipeline across various stages of development. The Director will manage analytical method life cycle including method development, qualification, testing, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf‑life strategy while ensuring full quality compliance with regulatory requirements and internal quality systems.
Key Responsibilities
Work with both internal (other CMC functions, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
Oversee batch release and stability testing, method development, qualification, transfer and validation activities at and cross CDMOs
Develop product specifications and oversee product in‑process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
Collaborate cross‑functionally with other CMC functions, QA and Regulatory to support tech transfers and lifecycle management, regulatory filing and interactions etc.
Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
Review and approve CDMO generated data, investigations, and documentation
Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
Serve as QC subject matter expert during regulatory inspections and audits
Qualifications
MS or PhD degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience
7+ years in Quality Control management for director level within the biotech or pharmaceutical industry
A strong quality compliance and collaborative mindset, and ability to thrive in a fast paced working environment
Strong knowledge of cGMP, FDA, EMA, and ICH regulations
Strong experience in analytical method development including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
Experience with common analytical techniques such as common compendial methods, HPLC/UPLC, CE‑SDS, ELISA, and cell‑based assays for biologics development
Proven leadership in managing internal QC operations or external CDMOs
Excellent communication, organizational, and problem‑solving skills
Position Location This is a fully remote role with up to 15% domestic and/or international travel.
As part of the I‑9 verification of authorization to work in the United States, Jade Bioscience participates in E‑Verify. To learn more about E‑Verify please review this poster.
Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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Get AI-powered advice on this job and more exclusive features.
Pay found in job post Retrieved from the description.
Base pay range $210,000.00/yr - $235,000.00/yr
About Jade Biosciences Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long‑term kidney function. A Phase 1 healthy‑volunteer study of JADE101 is ongoing, with interim, biomarker‑rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development.
Role Overview The Director, Quality Control will lead critical Quality Control activities to support Jade’s product pipeline across various stages of development. The Director will manage analytical method life cycle including method development, qualification, testing, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf‑life strategy while ensuring full quality compliance with regulatory requirements and internal quality systems.
Key Responsibilities
Work with both internal (other CMC functions, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
Oversee batch release and stability testing, method development, qualification, transfer and validation activities at and cross CDMOs
Develop product specifications and oversee product in‑process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
Collaborate cross‑functionally with other CMC functions, QA and Regulatory to support tech transfers and lifecycle management, regulatory filing and interactions etc.
Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
Review and approve CDMO generated data, investigations, and documentation
Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
Serve as QC subject matter expert during regulatory inspections and audits
Qualifications
MS or PhD degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience
7+ years in Quality Control management for director level within the biotech or pharmaceutical industry
A strong quality compliance and collaborative mindset, and ability to thrive in a fast paced working environment
Strong knowledge of cGMP, FDA, EMA, and ICH regulations
Strong experience in analytical method development including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
Experience with common analytical techniques such as common compendial methods, HPLC/UPLC, CE‑SDS, ELISA, and cell‑based assays for biologics development
Proven leadership in managing internal QC operations or external CDMOs
Excellent communication, organizational, and problem‑solving skills
Position Location This is a fully remote role with up to 15% domestic and/or international travel.
As part of the I‑9 verification of authorization to work in the United States, Jade Bioscience participates in E‑Verify. To learn more about E‑Verify please review this poster.
Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Referrals increase your chances of interviewing at Jade Biosciences by 2x
Get notified about new Director of Quality Control jobs in Greater Seattle Area.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr