Scientist II — Biochemistry & Microbiology for NPD/BI

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

Job summary

Advanced Sterilization Products is seeking a Scientist II in R&D Biochemistry & Microbiology to support NPD and sustaining BI production. You will work under supervision to develop procedures, test enzymes, culture microbes, and validate processes for sterilization and reprocessing applications.

Collaboration with cross-functional teams is essential to meet CTQ targets and regulatory standards. The role emphasizes microbial fermentation, process validation, and lifecycle management, with

Qualifications

• Bachelor’s degree in Microbiology, Biochemistry, Biomedical Engineering or related field with 3–5 years of experience.
• MS in Microbiology or equivalent with 0–2 years of applicable experience.
• Experience in Medical Device or other GxP-regulated industry.
• Experience with IQ/OQ/PQ and PV processes preferred.

Responsibilities

• Assist development and validation for NPD and BI production.
• Support microbial fermentation development and commercialization.
• Support lifecycle management and CAPA investigations.
• Ensure compliance with ISO and FDA guidance and documentation.

Skills

Biochemistry

Microbiology

Six Sigma

Lean

IQ/OQ/PQ

PV processes

Education

Bachelor’s degree in Microbiology/Biochemistry/Biomedical Engineering

MS degree in Microbiology

Tools

Analytical methods

Job description

Advanced Sterilization Products is seeking a Scientist II in R&D Biochemistry & Microbiology to support NPD and sustaining BI production. You will work under supervision to develop procedures, test enzymes, culture microbes, and validate processes for sterilization and reprocessing applications.

Collaboration with cross-functional teams is essential to meet CTQ targets and regulatory standards. The role emphasizes microbial fermentation, process validation, and lifecycle management, with