- 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.
- 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.
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Project Manager/Senior Project Manager, CMC - Philadelphia, United States - Cabaletta Bio
Description
Philadelphia, PA
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 CABATM 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 RESETTM (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 CABATM 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 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 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:
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.
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