Technical Operations Lead

Technical Operations Lead (Sr Manager to 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. Our teams engage across the entire drug development landscape, pursuing opportunities in discovery & mechanistic research, component design & screening, preclinical modeling, process & analytical development, translational & correlative studies, innovative clinical development strategies, and partnerships necessary to enable and transform our core technologies into groundbreaking cell-based medicines.

Roles & Responsibilities:

We are seeking a highly motivated Technical Operations Lead, reporting to the Vice President of Research & Development,  to develop and manage clinical supply chain solutions and logistics for our pipeline of T cell therapies
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This individual will play a key role in contributing to the development and execution of our evolving strategy for Technical Operations, spanning external manufacturing/CDMO oversight,  collaboration with process development & manufacturing personnel and partners, and clinical site enablement. This role requires a deep understanding of manufacturing for cell therapies, alongside strong technical skills in supply chain management and clinical operations support. This position offers the unique opportunity to contribute meaningfully to innovative therapies in the field of oncology. 

Key Responsibilities include:

Clinical Manufacturing and Supply Chain Management

·      Develop and execute end-to-end clinical supply chain strategy.

·      Oversee relationships with raw material suppliers and logistics vendors to ensure in-spec delivery of materials.

·      Establish and maintain supply chain processes, including inventory management, shipping tracking systems.

·      Establish secondary sources of consumables and reagents where possible.

·      Oversee CDMO clinical manufacturing scheduling, batch execution and release, and supply readiness.

·      Support review of executed batch records, deviations, investigations, and CAPAs related to clinical manufacturing activities.

·      Contribute to regulatory filings on manufacturing operations, supply chain, and clinical readiness.

·      Lead or support cross-functional meetings to ensure coordination on supply planning, temperature excursion management, and issue resolution across CMC, Clinical, and QA functions.

Clinical Operations Support

·      Partner with Clin Ops and CDMO to manage scheduling, coordination and execution of patient-specific manufacturing runs.

·      Ensure chain of custody requirements for all patient material movements.

·      Coordinate site readiness, including onboarding, training, apheresis handling, and

infusion logistics.

·      Support correlative sample collection, labeling, storage and shipment in coordination with clinical sites and central laboratories.

·      Oversee development of correlative assays using release assay platforms

Qualifications:

• BS/MS with a minimum of 10 years or PhD with a minimum of 5 years in the T cell therapy field in Manufacturing Sciences and Technologies, Tech Ops, or CMC roles; minimum of 5 years of industry experience required.
• Working knowledge of GMP, GCP, GDP and CMC expectations for early-phase trials.

What You Should Know

·      The base pay range for this position at commencement of employment is expected to be between $150,000-$190,000. 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 cultivating and fostering a diverse team, 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.

Please submit your resume/CV and cover letter via LinkedIn