Biologics GMP Startup & Single-Use Manufacturing Lead

Scorpion Therapeutics; California (MO); Hybrid; USD 180,000 - 250,000; Full time

Job summary

Gilead Sciences, Foster City, CA, seeks a Lead Biologics Drug Substance Single-Use GMP Manufacturing leader to oversee design, startup, and ongoing operations of the biologics manufacturing plant.

You will drive GMP startup execution, contribute to facility and equipment design input, lead process validation, ensure cGMP compliance, and push digital optimization across engineering, quality, and automation teams.

Qualifications

• BS in Science or Engineering with 8+ years of deep biologics drug substance manufacturing experience.
• Expertise in single-use technologies, process validation, and GMP compliance.
• Experience with FDA/EMA/ICH regulatory standards.

Responsibilities

• Direct technical execution during GMP startup.
• Support facility and equipment design input.
• Lead process validation.
• Ensure compliance with cGMP standards.
• Implement operational improvements.
• Provide leadership, coaching, and cross-functional collaboration across engineering, quality, and automation teams, emphasizing digital innovation and process optimization.

Skills

Biologics manufacturing

Single-use technologies

Process validation

GMP compliance

Bioprocess design

Automation

Digital manufacturing

Regulatory standards (FDA/EMA/ICH)

Education

Bachelor's degree in Science or Engineering

Tools

MES

SAP

Job description

Gilead Sciences, Foster City, CA, seeks a Lead Biologics Drug Substance Single-Use GMP Manufacturing leader to oversee design, startup, and ongoing operations of the biologics manufacturing plant.

You will drive GMP startup execution, contribute to facility and equipment design input, lead process validation, ensure cGMP compliance, and push digital optimization across engineering, quality, and automation teams.