Jobs
>
Philadelphia

    Director, Quality Assurance Operations - Philadelphia, United States - Cabaletta Bio

    Cabaletta Bio
    Cabaletta Bio Philadelphia, United States

    3 weeks ago

    Default job background
    Description

    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 CABATM 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 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:

    Reporting to the VP, Quality and Compliance, the Director, Quality Assurance Operations will provide quality oversight of production activities for Cabaletta Bio's CAART and CART GMP manufacturing. This includes supporting and approving manufacturing investigations and ownership over GMP quality projects. This position leads quality activities at Cabaletta's manufacturing partners. As primary GMP QA representative for the Cabaletta laboratories, this position will provide routine on-site guidance to laboratory personnel.

    Responsibilities:

    • Serve as the quality support for cell therapy manufacturing at CMOs and direct point of contact.
    • Provide management of compliance activities for site quality operations in accordance with Cabaletta SOPs and cGMPs.
    • Ensure CMC laboratory equipment, processes and analytical methods are qualified as appropriate.
    • Perform lot release of clinical materials.
    • Participate in Quality and Compliance planning and management meetings.
    • Develop and deliver regulatory required GMP training as required.
    • Review, comment, and approve (as appropriate) GMP related documents such as protocols, deviation investigations, change controls, CAPAs, reports, etc.
    • Perform or assist with CDMO and CTL quality investigations.
    • Perform or assist with product complaint investigations.
    • Support regulatory and conduct audits by ensuring inspection readiness within Cabaletta laboratories.
    • Function as the VP, Quality and Compliance's delegated backup when necessary.
    Qualifications:
    • Minimum of a bachelor's degree in a scientific discipline or equivalent.
    • 10+ years' experience in biotech/pharma, including demonstrated increasing levels of responsibility leadership experience a plus.
    • At least 5 years related QA/QC experience, preferably in cell or gene therapy.
    • Strong interpersonal, communication, teamwork, and analytical skills.
    • Highly proficient in Microsoft Word, Excel, and PowerPoint.
    • Strong working knowledge of cGMPs with knowledge of GLPs a plus.
    • Detail oriented with strong analytical and organization skills.
    • Ability to manage multiple tasks, establish priorities and work independently.
    • Strong team orientation and passion for continuous self-development.
    • Experience in industry or in a startup industrial setting is preferred.
    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

    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.
  • Cabaletta Bio

    Director, Quality Assurance Operations

    4 weeks ago

    Cabaletta Bio Philadelphia, United States

    Philadelphia, PACabaletta 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 CABATM platform includes two strategies to treat and potentiall ...

  • Iovance Biotherapeutics Inc

    Manager, Quality Assurance Operations

    2 weeks ago

    Iovance Biotherapeutics Inc Philadelphia, United States

    Job Description · Job DescriptionSalary: · Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are H ...

  • Iovance Biotherapeutics Inc

    Supervisor, Quality Assurance Operations

    2 weeks ago

    Iovance Biotherapeutics Inc Philadelphia, United States

    Job Description · Job DescriptionSalary: · Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are H ...

  • VALID8 Financial

    Director, Quality Assurance Operations

    3 weeks ago

    VALID8 Financial Wilmington, United States

    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 ...

  • All American Home Care

    CNA/CHHA Field Supervisor

    3 weeks ago

    All American Home Care Philadelphia, United States Full time

    The Field Supervisor is responsible for field operations and supervision of the implementation of care and treatment plans, therapeutic activities for individuals as directed by licensed practitioners. Participates in the development of treatment places, program functions as well ...

  • Temple Health

    eeg technician pool- temple university hospital

    2 weeks ago

    Temple Health Philadelphia, United States

    Job Description Description Performs standard diagnostic tests and special studies, which involve the operation of EEG equipment. Identifies artifact, describes abnormal clinical manifestations, assists in the evaluation of patients, collects data for quality assurance and assess ...

  • InsideHigherEd

    carot vector core director

    2 weeks ago

    InsideHigherEd Philadelphia, United States Faculty Jobs ,

    Duties: The GMP Core Director will assume responsibilities for production of gene therapy vectors intended for use in clinical development. This individual will be responsible for design, implementation, maintenance and continuous improvement of all core operations and components ...

  • Travel Nurse Across America

    IR Technologists

    2 days ago

    Travel Nurse Across America Philadelphia, PA, United States

    Put another $10,000 in your pocket when you take 5 assignments. Up to 15 weeks of vacation. For real. Apply for more details We are looking for IR Technologists (IR Tech) for an immediate travel opening in Philadelphia, PA. The right IR Tech should have 1 year of recent acute ca ...

  • Harris Computer

    Quality Assurance Engineer

    2 weeks ago

    Harris Computer Philadelphia, United States Full time

    Quality Assurance Analyst · SmartCOP, Inc - Remote · We are seeking a Quality Assurance Analyst to join our team. As a QA Engineer at SmartCOP, you will be placed into a small development team for our Records Management System software used by law enforcement and conservation e ...

  • InsideHigherEd

    asst. dean intramural practice

    2 weeks ago

    InsideHigherEd Philadelphia, United States

    Duties: Directly recruit and supervise the dentists and provide clinical direction to the Operations Director and clinical outreach staff. Devise strategies and plans for excellent service and growth. Oversee regulatory compliance, safety and standards of care. Develop, maintain ...

  • Beacon Hill

    Contract to Hire Quality Coordinator- Philly,

    5 days ago

    Beacon Hill Philadelphia, United States

    Our client, a highly impactful non-profit organization based in Philadelphia, is searching for a dedicated contract to hire Quality Assurance Coordinator to join their team. We are looking for an individual who possesses exceptional organizational skills and a sharp attention to ...

  • Beacon Hill

    Contract to Hire Quality Coordinator- Philly,

    4 days ago

    Beacon Hill Philadelphia, United States

    Our client, a highly impactful non-profit organization based in Philadelphia, is searching for a dedicated contract to hire Quality Assurance Coordinator to join their team. We are looking for an individual who possesses exceptional organizational skills and a sharp attention to ...

  • Bionic Prosthetics & Orthotics Group LLC

    Certified Prosthetist and/or Orthotist

    5 days ago

    Bionic Prosthetics & Orthotics Group LLC Philadelphia, United States

    Are you a motivated Certified Prosthetist and/or Orthotist based in the United States looking for an opportunity for career advancement with a dynamic organization? Bionic is the place for you · Bionic Prosthetics and Orthotics Group LLC is a leading and fast-growing ABC Accredit ...

  • Bionic Prosthetics & Orthotics Group LLC

    Certified Prosthetist and/or Orthotist

    4 days ago

    Bionic Prosthetics & Orthotics Group LLC Philadelphia, United States

    Are you a motivated Certified Prosthetist and/or Orthotist based in the United States looking for an opportunity for career advancement with a dynamic organization? Bionic is the place for you · Bionic Prosthetics and Orthotics Group LLC is a leading and fast-growing ABC Accredit ...

  • The Salvation Army

    Aquatics Attendant

    2 weeks ago

    The Salvation Army Philadelphia, United States Regular Part time

    Overview · Position : Kroc Aquatics Attendant (KAA) · Location/Dept. : Ray & Joan Kroc Corps Community Center, Philadelphia PA · Availability: Immediate · Schedule: 2 Part Time (up to 19 hours per week) positions available- Must be willing and able to work weekends and evenings ...

  • InsideHigherEd

    application developer c/sr

    2 weeks ago

    InsideHigherEd Philadelphia, United States Administrative Jobs ,

    Duties: WRDS is looking for an enthusiastic junior (C level) or senior developer to join the Platform Development and Integration team. You will work closely with the web and data teams, as well as marketing and our PhD researchers to present our data in innovative and easy to us ...

  • Southeastern Pennsylvania Transportation Authority

    Engineer III

    1 week ago

    Southeastern Pennsylvania Transportation Authority Philadelphia, United States

    OVERALL DESCRIPTION · Utilizing knowledge gained from three years of engineering experience, this position is responsible for undertaking engineering/quality assurance assignments that are considered to be of "basic complexity" in size and scope. This position is further respons ...

  • InsideHigherEd

    clinical safety manager

    2 weeks ago

    InsideHigherEd Philadelphia, United States Administrative Jobs ,

    Duties: The Clinical Safety Manager plays a pivotal role in the Clinical Operations function by serving as an expert to the Center for Cellular Immunotherapy (CCI) organization. The Clinical Safety Manager facilitates continuous improvement of CCI's proactive Serious Adverse Even ...

  • Bentley Truck Services Inc

    Automotive Parts Advisor

    2 weeks ago

    Bentley Truck Services Inc Philadelphia, United States

    Job Summary · The Parts Advisor supports and assists over all company goals in relation to Parts Sales goals, provides excellent service for our internal and external customers. The Parts Advisor will also have responsibility to assist customers over the phone in a proficient an ...

  • Global Life Science Hub

    Director, Quality Operations

    3 weeks ago

    Global Life Science Hub Philadelphia, United States

    Global Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania ...