Associate Director Analytical Development Jobs in Philadelphia, PA

Associate Scientist, Analytical Development - On-site, Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching 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 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

Position Summary

Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team, participating in a variety of analytical activities involved in lifecycle method management - method development and qualification, analytical testing support for projects at Process Development and CDMOs, CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs.

The successful candidate has opportunities to collaborate closely with CMC, Quality & Compliance, Supply Chain, and external partners.

Responsibilities

• Participate in the development, optimization, and qualification/validation of analytical methods, as required to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product and other advanced modalities, in compliance with relevant regulatory guidelines

• Perform analytical testing, supporting method development and qualification activities.
• Participate in technical oversight and serve as subject matter expert (SME) to CDMOs and external laboratories.

• Assist monitoring/trending of assay performance, investigation of assay deviations, out-of-specification, out-of-trend and out-of-expectation results at Analytical Development and external partners.
• Provide analytical expertise to Process Development, Manufacturing Sciences and Technology (MSAT), Quality & Compliance, and Quality Control

• Author and review method protocols, reports, and supporting documentation, ensuring compliance with GMP, GDP, and applicable regulatory requirements.

• Present in technical meetings and drive resolution of analytical-related issues.

Qualifications

• Bachelor's or master's degree in biology or closely related discipline with 2-4 years of experience.

• Proficient in aseptic techniques for cell culture and cell-based assays.
• Strong experience in analytic techniques, including flow cytometry, qPCR/dPCR, ELISA, HPLC etc.
• Demonstrated experience with analytical method qualification and validation.
• Experience working with CDMOs and contract testing laboratories in biologics, cell and gene therapy fields.
• Familiar with GMP compliance.

• Demonstrated scientific problem-solving, critical-thinking, and communication/ interpersonal skills, with attention to detail and strong organizational skills, and ability to manage multiple priorities in a fast-paced environment.

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.

#LI-ONSITE