Process Engineering Associate, Person-In-Plant

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 CABA™ 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 RESET™ (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 CABA™ 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 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

The Process Engineering Associate, Manufacturing Science and Technology (MS&T) is responsible for supporting clinical and commercial manufacturing production at Cabaletta’s cell therapy CDMO. This position will work very closely with manufacturing partners and requires frequent work onsite at manufacturing facility and occasional weekend and overtime work.

Responsibilities:

• The main responsibility will involve being sterile gowned in a manufacturing suite primarily acting as Cabaletta Bio’s person in plant (PIP) in a cGMP setting at a CDMO.  

• • • Oversight to ensure production runs in a smooth manner.   
    • Troubleshooting problems that may arise during manufacturing production and communicating to CDMO manufacturing supervisor and Cabaletta technical lead (if possible) in real-time.
    • Support CDMO manufacturing operator training program.
    • Support manufacturing related deviation investigations and CAPAs.
    • Support data capture of manufacturing production through excel and other data software.
    • Identify and support continuous improvement efforts between Cabaletta and the CDMO.
    • Review of batch records and other documentation to support product release activities.
    •  Ability to work off-shift, weekends and long hours as needed.
    • Ability to sit or stand for long hours.

• The secondary responsibilities will involve supporting manufacturing-related tech transfer activities.

• • • Support drafting documentation that will be supplied to the CMO which includes but not limited to: Batch Records, Work Instructions, forms and Memos.
    • Support and review CDMO documentation from draft to finalization.
    • Support any pre- clinical runs which could include verification runs, pilot runs and engineering runs at the CDMO. 

• Other responsibilities in the lab setting will also include:

• • • Work as part of Cabaletta MS&T team to support process development experiments and IND enabling experiments.
    • Following Cabaletta lab MPRs, SOPs, and work instruction to allow for the successful execution of these experiments.
    • Maintaining proper documentation of such activities via an electronic lab notebook.
    • Support lab shipping and receiving investigational material/ samples.
    • Maintain laboratory material and sample inventory, support the planning of MS&T process development materials needs and coordinate purchasing with lab manager.
    • Maintain all individual training requirements in a compliant state.
    • Other Job duties as assigned by manager.

Qualifications:

• Minimum Bachelor’s degree
• 1-2 years of experience in pharmaceutical / biotechnology or similar manufacturing cGMP.
• Excellent aseptic/sterile techniques and prior cell culture experience are required.
• Cell therapy manufacturing scale up experience is preferred.
• Experience with using cell processing related equipment, such as CliniMACS Prodigy, Sepax C-Pro, LOVO cell processing system, and Xuri bioreactor.
• Experience with handling and expanding T cells in cell culture bags or a bioreactor.
• Excellent skills in Microsoft word, Excel and some data analysis
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Self-motivated and understands flexibility in responsibilities.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

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.

#LI-HYBRID