- Provide support and oversight of CART drug product manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs)
- Provide as needed "person-in-plant" support and represent MDS&T on virtual plant teams
- Collaborate closely with Process Development, Analytical Development and Quality and provide technical expertise to successful resolution of technical issues
- Perform comprehensive manufacturing data analysis and trending
- Support technology transfer teams
- Participate in/lead risk management exercises, develop and document process FMEAs
- Preparation for and oversight of process performance qualification (PPQ) runs. Authoring of PPQ protocol and reports
- Authoring of relevant sections of regulatory filings and preparing responses to regulatory requests for additional information
- Responsible for technical evaluation and documentation of proposed changes to raw materials and product contact materials
- Develop platform standards and business process for raw materials and product contact consumables to stablish best practices to manage process performance variability owing to raw materials
- Lead the development of key quality attributes for critical raw materials used in drug substance and drug product manufacturing in partnership with Process and Analytical Development, Quality and Regulatory teams.
- Implement control strategy for key quality attributes of the critical raw materials
- Drive the use of data analytics for raw material evaluation to establish correlation between raw material attributes and process performance and product quality.
- Ph.D. in Biology, Chemistry, Biotechnology Sciences or Engineering with a minimum 2 + years direct work experience in biologics process development, process validation, or manufacturing under cGMP processes and ICH regulations, with specific experience in cell and gene therapy products or B.S. with 5 + years/M.S. with 3+ years direct work experience in biologics process development, process validation, or manufacturing under cGMP processes and ICH regulations, with specific experience in cell and gene therapy products
- Strong understanding and application of Lean manufacturing principles
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Experience of process validation lifecycle approach and risk assessments using a variety of tools, e.g. FMEA.
- Highly organized and efficient, strong team orientation and passion for continuous self-development.
- Ability to manage and coordinate parallel tasks across multiple projects, prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
- Experience contributing to preparation of documents for regulatory review, including but not limited to, INDs and BLAs.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
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Sr. Process Engineer, MS&T - Philadelphia, United States - Cabaletta Bio
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 CABATM 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 RESETTM (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 CABATM 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 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-CertifiedTM 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 position will serve as a senior team member and project leader, responsible for supporting ongoing clinical and future commercial manufacturing production at Cabaletta's cell therapy CDMOs. This position will be responsible for internal and external technology transfer and end-to-end manufacturing support for Cabaletta's current autologous CAR T manufacturing processes as well as future platforms. The incumbent will work closely with manufacturing partners, Supply Chain, Quality, Process and Analytical Development teams to provide guidance on manufacturing technical issues, advance strategic initiatives and implement processes for continuous improvement of manufacturing performance. The incumbent will be involved with drafting, review and approval of documents, and data generation and analysis as well presentations to senior management. This role will require onsite presence at manufacturing facilities and occasional weekend and or overtime work. This position will require up to 20% travel.
Responsibilities:
For more information, please visit
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.
