Cellares is seeking a highly motivated CMC Program Manager who will be responsible for managing CMC specific project timelines and activities related to Cell Therapy Manufacturing. The successful candidate will act as a bridge between CMC cross-functional teams, including Process Development, Analytical Development, Manufacturing, Regulatory Affairs, and Quality. Candidates should focus on successful program coordination and communication, both internally and externally. The successful candidate will be well versed in cell and gene therapy manufacturing, as well as experienced in Technical Operations/CMC project management and client relations.
This is a multidisciplinary role and this individual will interface across many parts of the company (with commercial teams, process, analytical, and operational groups) to develop the best solutions possible for our clients. Effective communication, positive relationship building, creative problem solving, and acting with a sense of urgency are essential for this role.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Manage and work with cross-functional teams to generate CMC strategies and timelines, identification and removal of project roadblocks, and risk mitigation planning
- Partner with Finance to manage program budgets and guide resourcing decisions, including forecasting and approval of invoices
- Support inventory management of custom reagents and materials, including drug substances
- Support preparation and planning of regulatory interactions and filings (e.g., FDA Master Files)
- Track outsourced activities as needed, including management of external vendors from evaluation to closeout, ensuring deliverables are met on time and within budget
- Continuous improvement of existing systems as well as implementation of new CMC program management best practices and tools
- Provide periodic updates via email, in-person, and/or Zoom with regard to project milestones, schedule, budget, and deliverables
- Investigate and resolve problems, identify root causes, and propose process improvements through clear communication with internal teams
- Capture and document requirements from external and internal stakeholders
- Generate program-related documentation, including but not limited to timelines, communication templates, status dashboards, tracking tools, presentation decks, and final reports
- Work with internal subject matter experts to assist in and respond to any partner or client questions and ad hoc requests during the duration of the program
- Continually work to streamline processes by creating more efficient methods of gathering, sorting, and accessing data
- Interface and develop strong working relationships with all internal subject matter experts across the organization
- Drive overall customer satisfaction and participation in future partnerships or adoption of Cellares’ Technology Solutions
- Lead cross-functional meetings and facilitate discussions internally and with external partners
Requirements
- Bachelor's degree or equivalent experience
- 5+ years of relevant professional experience
- Experience with project/program management in a manufacturing environment and interfacing directly with external partners
- Experience in a regulated biotech or pharmaceutical setting with proven competency and expertise in the CMC/GMP manufacturing space of cell-based therapies is highly desirable
- 1+ year of experience in client services directly interfacing with partners and/or clients
- Ability to understand and communicate scientific and business elements associated with engineered cell therapies
- Excellent verbal and written communication, time management, attention to detail, problem-solving, acting with a sense of urgency and enthusiasm
- High level of customer empathy with active listening skills
- Enjoys problem-solving in a dynamic and rapidly changing environment
- Experience using Google Apps, Project Management Tools (ie SmartSheet or TeamGantt) and CRM applications such as Salesforce
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
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