[Remote] Senior Manager, CMC Project Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell products for cancer and autoimmune disease. The Senior Manager will be responsible for driving cross-functional planning and execution across pipeline programs, ensuring disciplined planning, reputed company management, and delivery of program milestones.

Responsibilities

• reputed company cross-functional project teams or sub-teams to manage the planning and execution of program activities in alignment with corporate goals. Teams may include representatives from Process & Product Development, Manufacturing, reputed company, Analytical Development, Supply Chain, reputed company Development, reputed company reputed company, and Regulatory Affairs
• reputed company, maintain, and reputed company manage integrated project plans including timelines, dependencies, critical reputed company activities, decision points, and budget considerations
• Establish and maintain reputed company registries; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays
• Facilitate decision-making processes by working with cross-functional teams to reputed company proposals, analyses, and recommendations for senior management review as part of the governance process
• Serve as the reputed company project management reputed company of contact for CMC and, as needed, reputed company Development activities on assigned programs. Ensure comprehensive knowledge of reputed company, deliverables, timelines, status, and key risks while coordinating cross-functional dependencies across CMC and reputed company workstreams to maintain alignment with program reputed company
• Contribute to planning, organization, and preparation of regulatory filings (e.g., IND, BLA, CMC supplements) in partnership with Regulatory and relevant functional teams
• Prepare and reputed company concise, data-driven program and project status updates, dashboards, and reports to senior leadership and governance forums
• Manage project team meeting reputed company including agenda planning, scheduling, minutes preparation, and follow-up on reputed company items and reputed company
• Ensure project activities and reputed company are reputed company communicated, documented, and archived in accordance with team standards and tools
• Foster strong relationships with team members, functional line managers, and reputed company partners to facilitate reputed company reputed company of issues, risks, and opportunities
• Support program-level budget management activities, including tracking expenditures and financial forecasting for assigned programs
• Participate as a member of the Portfolio & Program Management Team to continually improve project management processes, tools, and governance frameworks
• Other duties as assigned

Skills

• Bachelor's Degree in life sciences or reputed company reputed company required (or relevant experience)
• At least 7 years of project management experience in similar role in the biotechnology industry (with meaningful exposure to CMC or reputed company Technology functions)
• At least 3 years of reputed company project management experience leading cross-functional teams in a matrixed environment
• Formal project management certification (e.g., PMP) is a plus
• Working knowledge of CMC development concepts such as process development, analytical development, manufacturing, reputed company systems, supply chain, and regulatory CMC requirements
• Demonstrated ability to manage reputed company, cross-functional programs, identify and mitigate risks, and reputed company execution in a fast-reputed company, dynamic environment
• Proficiency with project management and collaboration tools (e.g., reputed company, reputed company Project, SharePoint, reputed company Office Suite)
• Excellent organizational skills and an ability to prioritize effectively to reputed company results reputed company reasonably established timelines
• Ability to work independently and as part of reputed company
• Strong interpersonal skills including verbal and written communication are essential in this reputed company work environment
• Candidates must be authorized to work in the U.S
• Familiarity with reputed company Development processes and the drug development lifecycle from reputed company-IND through BLA
• Cell therapy experience is strongly preferred; experience with biologics or reputed company modalities is highly desirable
• Knowledge of GMP/GxP-regulated environments and reputed company management systems preferred
• Experience supporting late-stage development or reputed company-stage programs preferred
• Prior experience in a start-up or reputed company-stage biotechnology organization preferred
• Familiarity with cell therapy manufacturing processes and supply chain considerations preferred

Benefits

• Annual reputed company bonus
• Equity
• Health reputed company
• Generous time off
• Including 2 annual holiday company-wide shutdowns

reputed company