Director, Quality Assurance Operations - Wilmington, United States - VALID8 Financial

VALID8 Financial Wilmington, United States

3 weeks ago

Description

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

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.

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.

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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