Sr Manufacturing Technical Expert II

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

Role: Lead Biologics Drug Substance Single-Use GMP Manufacturing at Gilead’s new Foster City facility, overseeing design, startup, and ongoing operations of the biologics manufacturing plant.

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.

Requirements

• BS in Science or Engineering with a minimum of 8 years’ deep technical experience in biologics drug substance manufacturing, particularly with single-use technologies, process validation, and GMP compliance.


• Deep expertise in bioprocess design, automation, digital manufacturing, and regulatory standards such as FDA, EMA, ICH.

Preferred

• experience with process automation systems (e.g., MES, SAP), AI applications in manufacturing, and team management.

High-Value

• biologics (likely CHO-based), cGMP manufacturing startup, process validation, digital solutions, and regulatory interactions.

Work setup: hybrid in Foster City, CA, with leadership responsibilities spanning design, startup, and operational phases.