Associate Operations Manager, Translational Medicine

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

About the Position

This role can be hybrid or based out of our Philadelphia, PA office location.

The Translational Medicine Group (TMG) supports the clinical development of Cabaletta’s genetically engineered T cell therapies treating autoimmune diseases. In this cutting-edge field of Immunotherapy, translational medicine research strives to identify key biologic mechanisms contributing to patient responses to cell therapies. 

Reporting to the Operations Manager, Translational Medicine, we are seeking a highly motivated and detail-oriented Associate Operations Manager (AOM) within our Translational Medicine team.  This position offers a flexible hybrid work arrangement, combining both in-person and remote work with schedules coordinated with the hiring manager. The AOM will support our translational medicine sample management and data generation pipelines and foster collaborations with essential stakeholders across internal clinical operations, external vendors, and research partners. Additionally, the role includes responsibilities for managing clinical sample lifecycle activities. The ideal candidate will be self-driven and excel in both independent work and team collaborations.

Responsibilities:

• Work closely with the Operations Manager, Translational Medicine on the management and handling of clinical samples, both internally and externally, including supporting the shipping and receiving of clinical samples.


• Sample quality oversight: Including surveying data sources for TMG sample collection, processing and transit issues. Record sample deviations, manage and track implementation of CAPAs where applicable, in collaboration with Central Lab vendor(s) and the Quality team.


• Vendor Oversight: review invoices, evaluate vendor performance, build relationships with vendors and courier services.


• Reconcile informed consent for the use of clinical biospecimens to support translational scientists and external partners.


• Support on-site sample receiving and verification upon sample arrival.


• Coordinate timely shipments of clinical samples from central labs to testing labs/CROs and to our in-house lab team.


• Manage concurrent timelines for multiple internal projects.


• Review relevant sections of clinical study related documents.


• Support inventory buildout and testing workflows in TMG’s Laboratory Information Management System(s) (LIMS).


• Assist in timely review of CRO research contracts and invoices through communication with legal and finance groups respectively


• Enforce GLP-compliant and detailed record keeping protocols for clinical sample chain of custody (receipt, usage, etc.) within Cabaletta Bio


• Support TMG scientists in other related operational needs as project/priorities evolve

Qualifications:

• BS in a biological sciences or biomedical engineering-related field with 3+ years of experience in clinical drug development or an equivalent combination of education and experience.


• Experience in reviewing clinical protocol-associated documents including informed consent forms (ICFs) is highly preferred.


• Experience with clinical sample handling and inventory management is highly preferred. 


• Knowledge of requirements for biospecimen acquisition to support downstream analyses (i.e. flow cytometry, immunoassays, PCR, NGS)


• Highly organized, with the capacity to prioritize and provide consistent, timely responses working both collaboratively and independently.


• Strong communication skills required to interact effectively with internal and external stake holders, senior management, and external CROs.


• Management of contract research organizations is preferred.


• Previous exposure to translational science operations in the cell therapy field, including biospecimen sample processing and handling is advantageous.


• Strong team orientation and passion for continuous self-development.


• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.


• Previous experience with GLP/GCP & ICH regulations.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

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