Scientist, Process Development

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); On-site; USD 75,000 - 115,000; Full time

Job summary

An innovative biotechnology firm is seeking a Scientist in Process Development to refine and develop cutting-edge cell therapies. You will collaborate closely with various internal teams to ensure successful product transfer and optimize manufacturing processes. This role offers a unique opportunity to contribute to potentially curative therapies for autoimmune diseases, while fostering a culture of growth and teamwork. If you are passionate about advancing the field of cell therapy and eager to make a difference in patients' lives, this position is perfect for you.

Qualifications

• 2-3 years experience in cell and gene therapy or biologics process development.
• Strong knowledge of T-cells and immunological therapies.

Responsibilities

• Execute process development plans and ensure data integrity.
• Identify new technologies to enhance manufacturing outcomes.

Skills

Cell and Gene Therapy

Process Development

T-Cells Knowledge

Problem-Solving Skills

Communication Skills

Education

MS or PhD

Tools

Flow Cytometry

Cell-Based Bioassays

Job description

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.

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.

About the Position:

The Scientist, Process Development will be responsible for refinement, development, characterization, and assist transfer of product candidates through to Cabaletta’s cell therapy CMO. This position will work very closely with internal stakeholders (MSAT, AD, Pre-clinical, QA, CMC, Regulatory), and require up to 10% domestic travel or occasional weekend work.

Responsibilities:

• Execute process development experimental plans, provide associated protocols and final reports as needed, and present updates and data to teams.
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
• Maintain all individual training requirements in a compliant state.
• Support phase-appropriate cell therapy production processes using QbD principles.
• Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality.
• Maintain laboratory material and sample inventory, support the planning of process development materials needs and coordinate purchasing with lab manager.

Qualifications:

• MS or PhD with 2-3 years related experience in cell and gene therapy or biologics process development.
• Previous experience and working knowledge of T-cells or immunological cell therapies.
• In-depth experience with cell therapy process development and optimization is required.
• Experience with process characterization and regulatory requirements for late-stage process development.
• 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.

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.