Cabaletta Bio Inc

Reporting to the Director, QA Operations, the Manager / Senior Manager, GMP Quality Control is responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties.. The Manager / Senior Manager, GMP Quality Control will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant regulatory requirements.. Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports.. Minimum of 2 years hands-on experience in GXP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification. 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.

quality control

Philadelphia, PA Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases. Cabaletta Bio’s headquarters 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 Director, QA Operations, the Manager / Senior Manager, GMP Quality Control is responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties. This role involves developing, implementing, and maintaining Quality Control review processes to uphold the highest standards in internal and external laboratory activities. The Manager / Senior Manager, GMP Quality Control will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant regulatory requirements. Responsibilities <ul><li>GMP Compliance: ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP.</li><li>Batch Review / Release: Support clinical batch review and release by performing appropriate quality control review of all QC data generated by third parties. Identify issues of non-compliance, working directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner.</li><li>Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed.</li><li>Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed.</li><li>Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QA support of all activities.</li><li> Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner.</li><li>Training and Education: Assist in providing training and guidance to PD personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures.</li><li>Risk Management: Identify and assess potential risks related to GMP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues.</li><li>Continuous Improvement: Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality.</li><li>Communication: Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements to Quality Management. </li></ul>Qualifications <ul><li>Bachelor’s degree in a scientific discipline; Advanced degree preferred</li><li>Minimum of 5 years hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations</li><li>Minimum of 2 years hands-on experience in GXP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification</li><li>Prior clinical batch review experience preferred</li><li>Experience interacting with external testing laboratories preferred</li><li>Working knowledge of GMP and ICH guidance and both US and international regulatory requirements</li><li>Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently in order to appropriately prioritize work. </li><li>Strong team orientation and passion for continuous self-development.</li><li>Experience in industry or in a startup industrial setting is preferred. </li></ul>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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