CMC Project Manager
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Job Description
Job Description
A biopharmaceutical organization is looking to connect with experienced CMC Program Management professionals to support complex development and manufacturing initiatives. This role will coordinate cross-functional activities across technical, operational, and business teams. The ideal candidate will be highly organized, comfortable working in a regulated environment, and experienced in driving multiple workstreams toward shared milestones and deliverables.
Responsibilities- Coordinate cross-functional development and manufacturing initiatives from planning through execution.
- Develop and maintain project plans, timelines, milestones, action items, and program trackers.
- Partner with functional subject matter experts to establish priorities, dependencies, and deliverables.
- Facilitate team meetings and working sessions to drive alignment, decision-making, and issue resolution.
- Monitor project progress and proactively identify risks, dependencies, gaps, and potential delays.
- Maintain program-level tracking tools, including risk and action logs.
- Prepare concise program updates and reporting for functional and business leadership.
- Coordinate communication across technical and operational stakeholders to ensure alignment on priorities and timelines.
- Support planning activities related to development, manufacturing, process implementation, and other CMC workstreams.
- Assist with resource planning, prioritization, and cross-functional coordination.
- Support development and implementation of consistent project management processes and tools.
- Track program metrics and identify opportunities to improve execution and efficiency.
- Support multiple projects and competing priorities in a fast-paced environment.
- Bachelor's degree in a scientific, engineering, business, or related discipline.
- 5+ years of relevant experience in CMC, technical operations, project management, program management, or a related biopharmaceutical function.
- Experience managing cross-functional initiatives within a regulated life sciences environment.
- Familiarity with pharmaceutical or biotechnology development and manufacturing processes.
- Experience with project planning, timeline management, risk tracking, stakeholder communication, and program reporting.
- Strong organizational and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work effectively with technical and non-technical stakeholders.
- Ability to manage multiple priorities and work independently in a dynamic environment.
- Experience supporting CMC or technical operations programs.
- Experience within biologics, advanced therapies, or other complex biopharmaceutical development environments.
- Familiarity with GMP-regulated operations.
- Experience working across multiple technical functions or with external partners.
- Formal project or program management training/certification is a plus.
Vacancy posted 3 days ago
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