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Senior Director, Process Development - Wilmington, United States - VALID8 Financial
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, visitand 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.As a Senior Director, Manufacturing Data Science and Technology (MDS&T), you will play a pivotal role in leading and overseeing the end-to-end manufacturing, technology transfer and refinement of scalable cell therapy production processes.
This position demands a deep understanding of cell therapy processes, a strong background in bioprocessing, and the ability to drive innovation while ensuring regulatory compliance.
The Senior Director, MDS&T plays a critical role in advancing cutting-edge therapies that have the potential to transform patient care.
This position requires a combination of technical expertise, leadership, and a commitment to excellence in process development.Responsibilities:
Develop and execute the overall MDS&T strategy for cell therapy products, aligning it with the company's objectives and growth plans.
Drive technology transfer planning and execution across manufacturing network.
Ensure the scalability and robustness of processes to meet commercial production requirements.
Maintain a deep understanding of relevant regulatory guidelines and ensure that all process development activities adhere to regulatory standards (e.g., FDA, EMA).
Collaborate with regulatory affairs to support submissions and inspections.Build a best-in-class MDS&T team through recruitment, mentoring, and managing a high-performing team of scientists and engineers in process development.
Set clear objectives, provide guidance, and foster professional development.Facilitate the successful transfer of processes from development to manufacturing teams, ensuring seamless scale-up and technology transfer activities.
Collaborate with cross-functional teams, including manufacturing, quality, research, and clinical development, to achieve project milestones and goals.
Communicate progress and findings to senior leadership and stakeholders.
Manage the budget and allocate resources efficiently to support process development projects.
Ensure cost-effective strategies while maintaining quality standards.
Identify potential risks in the development process and implement mitigation strategies to ensure product success and patient safety.
Drive a culture of continuous improvement, implementing new technologies and best practices to enhance process efficiency and product quality.
Qualifications:
M.S. or equivalent in bioengineering or a relevant scientific discipline (e.g., cell biology, biotechnology).
15+ years' experience in process development within the cell therapy industry.
Strong knowledge of cell therapy manufacturing processes, including cell culture, cell expansion, gene editing, and downstream processing.
Proven leadership and team management skills, with a track record of building and leading high-performing teams.
Deep understanding of cGMP regulations and experience in regulatory interactions and submissions.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
Results-oriented mindset with a focus on achieving project goals and timelines.
Strong problem-solving skills and the ability to adapt to changing priorities in a dynamic environment.
Experience in technology transfer and process scale-up is a plus.
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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