R&D Biochem & Microbiology Scientist II

Advanced Sterilization Products; Irvine (CA); On-site; USD 81,000 - 136,000; Full time

Job summary

Advanced Sterilization Products (ASP) is seeking a Scientist II in R&D Biochemistry and Microbiology to support new product development and life cycle management for BI production. You will work with cross-functional teams including Operations and QA to improve procedures and ensure robust processes across the product lifecycle.

The role requires a bachelor’s degree in a scientific discipline with 3–5 years of experience or an MS with 0–2 years, plus 2+ years in a GxP-regulated environment.

Qualifications

• Bachelor’s degree in Microbiology, Biochemistry, Biomedical Engineering or a closely related field with 3–5 years of experience.
• MS degree in Microbiology or equivalent with 0–2 years of applicable experience.
• At least 2 years of experience in the Medical Device or other GxP-regulated industry; product development and/or manufacturing experience.

Responsibilities

• Support projects and activities related to biochemistry and microbiology for NPD and sustaining BI production.
• Analyze enzymes, culture for BI production, and analytes from cultivation, production, and application of microorganisms.
• Assist microbial fermentation development and commercialization.
• Support design changes for marketed products ensuring robust processes that meet CTQs and validations.
• Collaborate with manufacturing engineers to integrate product processes and systems.
• Apply Six Sigma/Lean tools to drive process improvements and new product introductions.
• Support life cycle management activities for BI products and CAPA investigations.
• Assist CIP, NPI, and change management projects focusing on microbiology.

Skills

Biochemistry

Microbiology

Bioprocess development

Quality systems

Data analysis

Education

Bachelor’s degree in Microbiology/ Biochemistry/ Biomedical Engineering or related field

MS degree in Microbiology or equivalent

Tools

IQ/OQ/PQ

Process validation

Job description

Advanced Sterilization Products (ASP) is seeking a Scientist II in R&D Biochemistry and Microbiology to support new product development and life cycle management for BI production. You will work with cross-functional teams including Operations and QA to improve procedures and ensure robust processes across the product lifecycle.

The role requires a bachelor’s degree in a scientific discipline with 3–5 years of experience or an MS with 0–2 years, plus 2+ years in a GxP-regulated environment.