Director

About Moonlight Bio Moonlight Bio is a Seattle-based, preclinical stage biotech company, pioneering the development of cutting-edge cell therapies for the treatment of cancer. Our team is comprised of highly collaborative individuals who are passionate about designing innovative technologies and drug candidates with the potential to transform the lives of cancer patients. Engaging across the full landscape of drug development, Moonlight’s team members are pursuing opportunities in discovery research, component design and screening, preclinical modeling, process and analytical development, translational studies, and external partnerships necessary to enable and advance our core technologies. Position Summary We are seeking a highly motivated and experienced Quality Assurance (QA) professional. The successful candidate will lead quality oversight for early phase clinical operations, manufacturing, and clinical supply of an autologous CAR T cell product, ensuring GMP and GCP compliance. This role will support the development, implementation, and maintenance of a phase-appropriate Quality Management System (QMS), with a strong emphasis on external vendor oversight, including GMP batch disposition and Clinical Data Oversight, and IND support for first-in-human studies. This position will provide both the strategic oversight of our quality vision and the hands-on execution of daily QA activities. Role & Responsibilities
Provide end-to-end quality oversight of manufacturing, including drug substance and drug product activities conducted at external CDMOs.
Ensure GMP readiness for clinical supply, including batch record review, deviation management and lot release.
Partner with CMC and CDMOs to support tech transfer, manufacturing campaigns, and release testing for clinical material.
Establish and execute clinical supply quality strategy, ensuring compliance of stability programs, reference standards, and comparability assessments as applicable.
Partner with Clinical Operations and CROs to ensure early phase GCP compliance, including site audits, trial master file reviews, and investigator compliance.
Implement and maintain a phase-appropriate QMS to support GXP compliance, including SOP development and maintenance, document control, deviation and CAPA systems, change control, and training programs.
Lead qualification, onboarding, and ongoing oversight of third-party vendors and contract organizations (CROs, CDMOs) through audits, quality agreements, and performance monitoring.
Provide quality oversight for IND-enabling studies, including analytical method validation, bioanalytical testing, toxicology, and study reports.
Ensure compliance with FDA and ICH regulations applicable to IND submissions, including data integrity and documentation standards.
Collaborate cross-functionally with CMC, Clinical Operations, Regulatory, Nonclinical, and Program teams to ensure quality is integrated into all processes.
Provide support for any quality-related responses to regulatory agencies.
Serve as the quality subject matter expert during the IND submission process. Qualifications
Bachelor’s or advanced degree in life sciences or a related discipline.
12+ years of experience in biopharmaceutical industry, preferably with GMP roles, including direct experience working in QA.
QA or QC experience specific to Cell and Gene Therapy Products is preferred
Strong knowledge of FDA and ICH guidelines.
Experience with CRO/CDMO oversight, including vendor audits, qualification, and management.
Familiarity with electronic quality systems and tools for document management.
Prior experience supporting IND submissions and agency responses is highly desirable.
Prior experience building a quality system from the ground up is highly desirable.
Experience working in venture-backed startups or early-stage biotech companies is a plus.
Excellent interpersonal, communication, and organizational skills.
Comfortable in a hands-on, roll-up-your-sleeves startup environment. What you should know
The base pay range for this position at commencement of employment is expected to be between $185K-$215K per year.
The base pay offered may vary depending on a variety of individualized factors, including the relevance, and years, of the applicant’s experience, job-related knowledge, skill set, certifications, qualifications, and/or professional licenses held, and market location.
Full time employees (and their eligible dependents) will be eligible for employee benefits including PTO, medical, dental, and vision plans from the first day of employment. Further, Moonlight supports its team members in pursuing certifications, conferences, and training relevant to their roles. At Moonlight Bio, we are committed to providing equal employment opportunities to all employees and applicants without regard to characteristics and statuses protected under applicable federal, state, and local laws. Applicants must be authorized to work in the United States. Moonlight Bio will not sponsor applicants for work visas. Join us at Moonlight Bio and contribute to groundbreaking research that has the potential to create innovative and powerful new cancer therapies! With our collaborative, team-centric R&D approach, and our dedication to professional development, you’ll have the opportunity to make a meaningful impact on patients’ lives while advancing your career in the dynamic field of cell therapy.