Analytical PM

Analytical Project Manager

Job Title: Analytical Project Manager – Gene Therapy (Remote)

Location: Remote

Company Overview:

Join a cutting-edge gene therapy company committed to advancing transformative therapies for rare and complex genetic disorders. We are dedicated to delivering innovative treatments to improve patients’ lives.

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. The ideal candidate has transitioned from a gene therapy scientist role to project management and has a deep understanding of analytical processes and regulatory expectations in gene therapy development.

Key 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.

Qualifications:

- 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.