CMC Program Manager

August 23

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Cellares

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Accelerating Access to Life-Saving Cell Therapies

biotech • biotechnology • cell therapy • manufacturing • software

51 - 200

💰 Series C on 2023-08

Description

• 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