Processing Associate Jobs in Souderton, PA (NOW HIRING)

Position Title: Associate Scientist, Process Development

Location: Philadelphia, PA, On-Site

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

About the Position:

The Associate Scientist, Process Development (PD) will be responsible for refinement, development, and assist in transfer of product candidates through to Cabaletta's cell therapy CDMOs. This position will work very closely with internal stakeholders (e.g. MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners, and require up to 10% domestic travel or occasional weekend and overtime work.

Responsibilities:

• Execute process development experimental plans, provide associated protocols and final reports as needed, and present updates and data to teams.
• Design and execute Design of Experiments (DoE) studies to support process improvement, process characterization, and evaluate their impact on critical quality attributes (CQAs) and process performance.
• Support phase-appropriate cell therapy production processes using QbD principles.
• Assist the transfer of process to CDMOs for cGMP clinical manufacturing.
• Develop and review electronic Batch Records (eBRs) to support clinical manufacturing, ensuring alignment with process requirements, manufacturing procedures, and GMP expectations.
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
• Maintain all individual training requirements in a compliant state.
• Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality.
• Coordinate with internal groups and external partners, scheduling and tracking clinical patient material/product shipping and receiving, troubleshooting associated issues.
• Maintain laboratory material and sample inventory, support the planning of MS&T process development materials needs and coordinate purchasing with lab manager.

Required Qualifications:

• B.S. with 3 + years or M.S. with 1 + years' experience within process development and manufacturing under cGMP processes.
• Previous experience and working knowledge of T-cells or immunological cell therapies.
• Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required.
• Experience in process automation is a plus.
• Experience in flow cytometry and cell-based bioassays is a plus.
• Good working knowledge in cGMP manufacturing of biological process and ICH regulations.
• Good coordination and communication skills are required.
• Highly organized and efficient, able to work independently. Strong problem-solving skill is preferred.
• Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

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