Research Operations and Nonclinical Development ManagerPosition Summary:The
Research Operations and Nonclinical Development Manager provides operational, laboratory, and project management support to the Discovery Research and Nonclinical Development functions. This role ensures scientists have the materials, infrastructure, external partnerships, and project oversight required to advance cell and gene therapy programs efficiently from discovery through IND-enabling nonclinical development.
Reporting to the VP, Head of Discovery Research, the individual will initially spend significant time supporting laboratory operations and research activities to build a strong understanding of Cartesian's platforms, workflows, and development programs. As the organization grows, the role is expected to assume increasing responsibility for nonclinical project management, including coordination of CROs, vendors, study timelines, budgets, and regulatory-supporting activities.
The ideal candidate combines scientific training with strong organizational and project management skills, enjoys working in a dynamic biotechnology environment, and is comfortable collaborating with scientists, technical development teams, and external partners.
Key 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 partner 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 ensure timely execution of study objectives 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, proactively identifying and resolving 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 decision-making.
- Implement and continuously improve laboratory operations and project management processes, tools, dashboards, and workflows to enhance organizational efficiency and support future portfolio growth.
Qualifications:Required- Bachelor's degree in Biology, Biotechnology, Immunology, Life Sciences, Biomedical Engineering, or a related discipline.
- 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.
Preferred- 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.
Work Environment: - This position is based in Frederick, Maryland, and requires regular onsite laboratory presence.
- Comply with all company safety policies, EH&S requirements, laboratory procedures, and applicable regulations.
- May work in areas where biological materials, chemicals, and laboratory equipment are present; required training and personal protective equipment (PPE) will be provided.
- Promote and support a safe, organized, and compliant laboratory environment.
- Ability to move throughout laboratory and office spaces and occasionally lift and transport materials up to 25 pounds, with or without reasonable accommodation.
Salary Notice:At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $90,000 - $115,000 per year. This position is also eligible for an annual bonus and equity within the company. Please note that the final compensation will be determined based on several factors, including but not limited to years of experience, industry experience, education, and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process. Please, no agency or recruiter inquiries. Unsolicited resumes will not be accepted and no fees will be paid for unsolicited candidates.
