Project Manager/Senior Project Manager, CMC

Philadelphia, PA

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

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 Senior Director, Technical Operations, the Project Manager / Senior Project Manager, CMC will provide support to internal project teams in performing cross-functional drug development activities of pipeline products at Cabaletta.

In addition, you may be asked to lead and / or participate in special department, cross-functional, or team projects.

Responsibilities

• Develop and maintain project CMC project plans, incorporating activities, internal / external requirements, and key interdependencies to deliver tangible results against program and corporate goals.
• Direct and coordinate multiple projects to ensure on-time and on-budget delivery.
• Identify, define, prioritize, and communicate risks to successful project execution; develop and monitor risk mitigation and contingency plans.
• Provide team meeting management including meeting agenda, action plans, and thorough follow-up.
• Maintain financial accountability for assigned projects ensuring budgets are established, followed, and change controls managed appropriately.

Communicate project status to stakeholders and key project participants.

• Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs.
• Support the management of external suppliers, including contract manufacturing and development organizations (CDMOs), to ensure timely and high-quality delivery of CMC-related activities.
• Create presentations, dashboards, and reports to communicate project status, key internal metrics, and / or risk mitigations.

Qualifications

• Bachelor's degree required with a specialization in science, engineering, or health related field preferred. PMP, or other project management certification preferred but not required.
• 5+ years of CMC experience supporting project operations within a biotechnology or pharmaceutical environment. Cell and / gene therapy experience preferred.

Experience support CDMOs required.

• History of motivating others to deliver on important milestones while maintaining a positive, transparent, and collaborative team environment.
• Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word) and MS Project or Smartsheet.
• Capable of creating / updating detailed cross functional project timelines and to guide and align study team members in terms of planning and executing against the timelines.
• Ability to generate high quality meeting minutes and project materials, such as presentations, action trackers, budget, and cross functional resource plans in conjunction with the PTL, team members and functional leads.
• Must display strong analytical and highly proactive problem-solving skills.
• Excellent verbal and written communication, strong organizational and interpersonal skills
• Ability to work both independently and collaboratively with cross-functional teams.
• Ability to work in a dynamic, fast-paced, timeline-based environment.
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in ap 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 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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