Director, CMC Project Management
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Job Description
CMC project director advancing ProKidney’s cell therapy programs toward BLA filing and approval. Leading cross-functional planning, risk management and Technical Operations deliverables.
Responsibilities:
- Manage CMC planning activities supporting late-stage and commercial CMC regulatory submissions, BLA filing, PLI and approval
- Identify CMC gaps and implement cross-functionally aligned CMC strategy
- Translate CMC strategy into project plans with defined deliverables and deadlines
- Drive cross-functional teams and manage interdependencies across Technical Operations
- Develop, maintain and track detailed CMC plans and major milestones
- Identify program risks and develop and monitor risk mitigation and contingency plans
- Facilitate CMC gap assessments, risk analyses, strategy discussions and cross-functional decision-making
- Lead data-driven recommendations for project continuation, acceleration, reprioritization, redesign or termination
- Provide status reports, document deliverables and escalate timeline slips, risks and unresolved dependencies
- Serve as primary CMC contact for internal stakeholders and represent CMC at project team meetings
- Lead and prioritize project managers supporting CMC projects
- Own CMC planning standards, templates and cadence
- Communicate project updates to team members and executives
- Collaborate with Operations, QA, RA and CMC teams on technology transfer, comparability, process scale-up and validation activities
- Contribute to CMC planning within Integrated Development and Integrated Project Plans
- Report on a defined cadence to provide CMC plan details for the Integrated Project Plan
Requirements:
- Bachelor's degree in sciences or related field; advanced degree (MS, PhD) preferred
- 12+ years of relevant biopharmaceutical industry experience
- 6+ years of cell therapy experience
- Prior background in CMC project management at a biotech/pharma company focused on biologics/cell & gene therapy
- Experience leading project managers or a project management team
- Technical understanding of the interdisciplinary nature of cell therapy development
- Sufficient CMC depth to identify dependencies, risks and gaps across manufacturing, quality, analytical and regulatory activities
- Proven track record of effective collaboration with cross-functional CMC teams
- Demonstrated ability to multitask across product pipelines and support short- and long-term corporate goals
- High ethical standards and compliance focus
- Must be eligible to work in the United States without work visa or residency sponsorship
Benefits:
- Equal employment opportunity employer
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
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