Project Manager/Lead Scientist-Cell and Gene Therapy

Job Title: Analytical Project Manager-Gene Therapy Reports to: Associate Director of CMC Location: Remote Based Company HQ: California Company Overview: Join a cutting-edge gene therapy company committed to advancing transformative therapies for rare and complex genetic disorders. The company is based in California yet this is a remote based role. Position Overview: We are seeking an experienced and driven Analytical Project Manager to lead and manage cross-functional teams within our gene therapy development projects. This remote-based position requires someone with a strong scientific background in gene therapy, particularly within Chemistry, Manufacturing, and Controls (CMC), and hands-on laboratory experience. • Lead and manage analytical activities for gene therapy projects, ensuring project milestones are met on time and within scope. • Oversee CMC-related aspects of gene therapy product development, focusing on analytical strategies and compliance with regulatory guidelines. • Coordinate and communicate with cross-functional teams, including research scientists, manufacturing, quality assurance, and regulatory teams. • Develop and maintain detailed project plans, timelines, and risk assessments, ensuring alignment with overall project goals. • Serve as the point of contact for internal stakeholders and external partners to ensure smooth collaboration. • Track and report project progress, identifying any potential roadblocks and providing solutions to mitigate risks. • Ensure compliance with relevant industry standards and regulatory requirements. • Manage project budgets and resources efficiently to meet project deliverables. • 3-5 years of experience working in gene therapy, with prior experience as a scientist focused on CMC. • Proven experience transitioning into a project management role, with a strong understanding of project management methodologies and tools. • Solid understanding of the analytical requirements in gene therapy development, including assay development, process development, and regulatory submissions. • Experience working with cross-functional teams and managing complex projects within the gene therapy space. • Excellent organizational, communication, and leadership skills. • Ability to work independently in a remote environment while managing multiple projects simultaneously. • PMP certification or formal project management training is a plus. Education: • Bachelor’s, Master’s, or Ph.D. in Life Sciences, Biotechnology, or a related field with a focus on gene therapy.Apply Now

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