QC Manager

OVERVIEW

Gator Bio (formerly known as Probe Life) is a pre-IPO biotech company located in Palo Alto, CA. We are creating innovative technologies to solve difficult problems facing today’s healthcare industries. We develop, manufacture and market instruments, biosensors, reagents, and consumables for in-vitro diagnostics and biotherapeutic development. Our mission is to simplify and accelerate biological analysis for biotherapeutic research and development.

We are hiring for a full-time QC Manager to be based in Palo Alto. This position will be responsible managing a GMP compliant analytical laboratory. 

RESPONSIBILITIES

• Management of GMP analytical laboratory operations and personnel.
• Prepare QC Standard Operating Procedures.
• Development of lab staff in GMP understanding and compliance.
• Hands-on performance of QC immunochemistry assay method transfer/ validation and release testing.
• Lead QC analytical method troubleshooting and out of specification results laboratory investigations.

REQUIREMENTS

• BS or MS in biology, chemistry, biochemistry, or other related science.
• At least 5 years’ experience working in a GMP laboratory.
• Minimum 2 years of personnel management experience preferred. 
• Must have in depth knowledge of FDA GMP regulation related to a QC laboratory.
• High level of integrity, flexibility, and teamwork.
• High attention to detail; excellent organizational skills; ability to work on multiple projects.
• Ability for problem-solving and decision-making.
• Experience in immunochemistry is a plus.
• Excellent interpersonal and verbal communications skills.
• Proficient in Microsoft Office Suite - Word, Excel, PowerPoint, etc