Research Operations and Nonclinical Development Manager

Cartesian Therapeutics•Frederick, MD

14h•Onsite

About The Position

Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for autoimmune diseases. Its lead asset, Descartes-08, is in Phase 3 clinical development for generalized myasthenia gravis, Phase 2 development for myositis (including dermatomyositis and antisynthetase syndrome), and Phase 1/2 development for pediatric autoimmune diseases, including juvenile dermatomyositis. The Research Operations and Nonclinical Development Manager provides operational, laboratory, and project management support to Discovery Research and Nonclinical Development. The role ensures scientists have the materials, infrastructure, external partnerships, and project oversight needed to advance cell and gene therapy programs from discovery through IND-enabling nonclinical development. Reporting to the VP, Head of Discovery Research, the manager will initially focus significantly on laboratory operations and research support to learn the company's platforms, workflows, and programs. As the organization grows, the role will take on increasing responsibility for nonclinical project management, including CRO and vendor coordination, study timelines, budgets, and regulatory-supporting activities. The position is based in Frederick, Maryland and requires regular onsite laboratory presence. The employee must follow company safety policies, EH&S requirements, laboratory procedures, and applicable regulations. Work may involve areas with biological materials, chemicals, and laboratory equipment; required training and PPE will be provided. The role requires moving through laboratory and office spaces and occasionally lifting and transporting materials up to 25 pounds, with or without reasonable accommodation.

Requirements

Bachelor's degree in Biology, Biotechnology, Immunology, Life Sciences, Biomedical Engineering, or a related discipline.
At least 5 years of experience in biotechnology, pharmaceutical, contract research, or life science organizations.
Experience supporting laboratory operations, research programs, technical development activities, or external studies.
Strong project management, organizational, and communication skills.
Experience coordinating multiple activities across internal teams and external vendors.
Demonstrated ability to manage timelines, budgets, priorities, and documentation.
Proficiency with Microsoft Office, Teams, Project, or similar project tracking platforms.
Ability to work independently in a fast-paced, evolving environment.

Nice To Haves

Direct experience supporting nonclinical development programs, translational research, or IND-enabling studies.
Experience coordinating CROs conducting pharmacology, toxicology, biodistribution, PK/PD, immunogenicity, or cell and gene therapy studies.
Familiarity with GLP regulations, ICH guidance, and regulatory expectations for biologics, cell therapy, and gene therapy products.
Experience with cell therapy, gene therapy, mRNA, immunology, autoimmune disease, or oncology programs.
Formal project management training or PMP certification.
Experience working in a startup or emerging biotechnology company.

Responsibilities

Coordinate day-to-day laboratory operations, including inventory management, consumable ordering, sample logistics, equipment maintenance, and laboratory organization.
Provide hands-on laboratory support as needed, including reagent management, sample organization, preparation of study materials, and support of research workflows.
Maintain laboratory records, SOPs, equipment inventories, operational documentation, and a safe, efficient research environment.
Support onboarding of new employees and work with Facilities, EH&S, IT, Quality, and other functions to address laboratory operational needs.
Plan, coordinate, and track nonclinical studies supporting cell and gene therapy programs, including pharmacology, biodistribution, toxicology, immunogenicity, and other IND-enabling activities.
Maintain integrated project plans, timelines, milestone trackers, risk registers, budgets, and action-item logs across discovery and nonclinical programs.
Serve as the primary operational liaison with CROs, testing laboratories, consultants, and external vendors to support timely study execution and deliverables.
Coordinate study start-up and execution activities, including quotations, contracts, statements of work, budgets, schedules, material transfers, sample shipments, and study logistics.
Monitor study progress, vendor performance, timelines, deliverables, risks, deviations, and external spending, and proactively identify and resolve operational challenges.
Organize project team meetings, document decisions and action items, and facilitate communication among internal stakeholders and external partners.
Support preparation, review, collection, and organization of study reports and supporting documentation for regulatory submissions and development decisions.
Implement and improve laboratory operations and project management processes, tools, dashboards, and workflows to enhance efficiency and support portfolio growth.
Comply with company safety policies, EH&S requirements, laboratory procedures, and applicable regulations, and promote a safe, organized, and compliant laboratory environment.