Project Manager/Lead Scientist-Cell and Gene Therapy

Project Manager/Lead Scientist-Cell and Gene Therapy

Description

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.

Responsibilities

• 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.