Associate Operations Manager, Translational Medicine

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

Uniquely Differentiated. Rapid. Elegant

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ 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

Reporting to the Senior Scientist, Translational Medicine we are seeking an experienced, motivated, detail-oriented, and highly skilled Senior Research Associate/Associate Scientist within our Translational Medicine team.

Under scientific and technical supervision, the individual will be primarily responsible for developing and performing a host of different molecular assays that will support our understanding of Cabaletta Bio’s cellular therapies investigated in various clinical trials. More specifically, the candidate will be utilizing Luminex based assays to evaluate serum antibody levels, dPCR to interrogate drug product concentration, and MSD (Meso Scale Discovery) to measure multiple serum biomarkers. As part of the Translational Medicine team, the individual must be able to perform qualified assays on clinical trial participant materials, adhering to internal compliance standards. 

Responsibilities:

• With guidance from a Senior Scientist, Translational Medicine, perform translational assays on clinical samples and potentially pre-clinical samples.
• Perform qualified or validated molecular based assays (Luminex, dPCR, MSD etc.) on clinical samples to inform on cell product persistence, activity, and efficacy in humans.
• Perform correlative molecular assays with close attention to detail and adhering to tight timelines at certain times.
• Participate in generating, qualifying, and validating GLP-like assays and author corresponding SOPs, where applicable.
• Interface heavily with the electronic lab notebook (eLN) system and sample management system; accurately capturing sample metadata and assay data in a timely manner, ensuring data integrity and protocol compliance using an eLN.
• Maintain GDP-compliant and detailed records for clinical sample lifecycle (receipt, usage, inventory, etc.).
• Involvement in clinical sample accessioning with close attention to metadata entry.
• Opportunities to learn and perform cell-based assays such as flow cytometry and cell killing assays.
• Excellent time-management skills and ability to manage multiple internal projects / workstreams simultaneously.
• Perform lab associated tasks in accordance with GLP and Cabaletta Bio lab safety policies and SOPs.
• Have a team-first mentality by maintaining laboratory space and contributing to weekly activities.

Qualifications:

• MS degree in Biology, Immunology, Engineering or related field or Bachelor’s degree with 2 years of experience in an academic laboratory or the biotechnology industry is required.
• Experience with molecular based assays such as Luminex, dPCR, and/or MSD.
• Significant lab experience including aseptic technique, mammalian cell culture, human tissue handling, and plated cell-based assays.
• Must be able to follow SOPs and follow good documentation practices (GDP).
• Must be highly organized and efficient, able to work independently. Strong problem-solving skills are preferred.
• Must be able to communicate clearly verbally and in writing.
• Must have a desire to be part of a growing organization that uses cutting-edge science.
• 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.

Preferred Skills:

• Experience in protocol design, qualification, and SOP generation.
• Experience with the Luminex platform.
• Experience with the MSD platform.
• Experience with a digital PCR platform.
• Experience with clinical sample handling and inventory management is highly preferred.
• Experience troubleshooting, qualifying, or validating molecular based assays.  
• Experience in the biotechnology industry or in a startup industrial setting.
• Previous experience with GLP/GCP & ICH regulations.
• Prior use of an electronic laboratory notebook system; involvement in system development is a plus.

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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