Director, CMC Project Management

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

👻 Ghost score 10%

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ProKidney Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

ProKidney Corp. is a late clinical-stage biotechnology company focused on pioneering cell therapy as a treatment for Chronic Kidney Disease (CKD). Their innovative approach aims to transform the therapeutic options available for advanced CKD by preserving kidney function, potentially delaying or eliminating the need for dialysis. With a focus on an area of high unmet medical need, ProKidney's cell therapy candidate, rilparencel, is at the forefront of clinical studies to provide alternative solutions for patients with limited treatment options. The company is committed to advancing its pipeline through clinical and regulatory developments and actively participates in healthcare conferences to bring attention to its groundbreaking work in CKD treatment.

📋 Description

• 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