CMC Program Manager — Cell Therapy & Regulatory Lead

Gameto; Austin (TX); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Job summary

A pioneering biotech company is seeking a CMC Program Manager in Austin, Texas to lead cross-functional initiatives supporting groundbreaking therapies in women's health. This mid-senior level role involves coordinating CMC activities, managing external partnerships, and ensuring regulatory compliance. Candidates should have a background in project management and a degree in life sciences or engineering. Join a mission-driven team pushing the boundaries of women's health innovation.

Qualifications

• 1-3 years of experience in project/program management in a biotech or pharmaceutical environment.
• Prior experience leading external partnerships and managing deliverables from CDMOs or other vendors.
• Familiarity with CMC regulatory deliverables and development lifecycle of cell or gene therapy products.

Responsibilities

• Coordinate and manage CMC activities across internal departments.
• Serve as the main point of contact for external partners.
• Develop and maintain integrated timelines, project plans, and risk registers.

Skills

Project management

Strong communication

Organizational skills

Education

Bachelor's degree in life sciences or engineering

Advanced degree or PMP certification

Job description

A pioneering biotech company is seeking a CMC Program Manager in Austin, Texas to lead cross-functional initiatives supporting groundbreaking therapies in women's health. This mid-senior level role involves coordinating CMC activities, managing external partnerships, and ensuring regulatory compliance. Candidates should have a background in project management and a degree in life sciences or engineering. Join a mission-driven team pushing the boundaries of women's health innovation.