Senior Manager, CMC Project Management (Biotech)

TL;DR

Senior Manager, CMC Project Management (Biotech): Leading cross-functional planning and execution for clinical-stage cell therapy programs with an accent on CMC development, risk management, and regulatory alignment. Focus on driving complex drug development milestones from Pre-IND through BLA in a fast-paced, matrixed environment.

Location: Hybrid in South San Francisco, CA (US-based, west coast remote may be considered)

Salary: $150,000–$170,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Lead cross-functional project teams across Process Development, Manufacturing, Quality, and Clinical Operations.
• Develop and manage integrated project plans, timelines, critical path activities, and budgets.
• Establish risk registries, identify potential bottlenecks, and define mitigation strategies.
• Facilitate decision-making processes and prepare data-driven status updates for senior leadership.
• Coordinate regulatory filing preparations including IND, BLA, and CMC supplements.
• Manage project team operations, including meeting facilitation and documentation of key decisions.

Requirements

• Bachelor’s degree in life sciences or related field.
• At least 7 years of project management experience in the biotechnology industry.
• At least 3 years of direct experience leading cross-functional teams in a matrixed environment.
• Working knowledge of CMC development concepts (process development, manufacturing, quality, supply chain).
• Must be authorized to work in the U.S.

Nice to have

• Formal project management certification (e.g., PMP).
• Experience with cell therapy or complex biologics.
• Familiarity with Clinical Development processes and GxP-regulated environments.
• Experience in a start-up or growth-stage biotechnology organization.

Culture & Benefits

• Collaborative environment with a focus on developing life-changing therapies.
• Competitive compensation package including annual performance bonus and equity.
• Comprehensive health insurance and generous time off.
• Two annual company-wide holiday shutdowns.