Biochemistry & Microbiology Scientist II — R&D & BI

Industrial Scientific Corporation; Irvine, Northern (CA, KY); Hybrid; USD 81,000 - 136,000; Full time

Job summary

Advanced Sterilization Products in Irvine, CA is seeking a Scientist II in R&D Biochemistry and Microbiology to support development and lifecycle activities for biological indicators and sterilization technologies. You will work with cross-functional teams to develop procedures, validate processes, and ensure ISO and FDA compliance throughout product lifecycles.

The role requires a bachelor’s degree in a scientific field with 3–5 years of related experience, or a MS with 0–2 years.

Qualifications

• Bachelor’s degree in Microbiology, Biochemistry, Biomedical Engineering or related field with 3–5 years of experience.
• MS degree in Microbiology or related field with 0–2 years of experience is acceptable.
• Experience in Medical Device or other GxP-regulated environments is preferred.

Responsibilities

• Support NPD and sustaining BI production projects from R&D and operations.
• Assist in development and validation of biochemistry/microbiology procedures.
• Collaborate with cross-functional teams to meet CTQ’s and ensure regulatory compliance.
• Contribute to CAPA, IQ/OQ/PQ activities and documentation.

Skills

Data analysis

Study protocols

Problem solving

Cross-functional collaboration

Quality systems

Education

Bachelor's in Microbiology/Biochemistry/related

MS in Microbiology or related (0–2 yrs)

Tools

GxP-regulated experience

IQ/OQ/PQ processes

Job description

Advanced Sterilization Products in Irvine, CA is seeking a Scientist II in R&D Biochemistry and Microbiology to support development and lifecycle activities for biological indicators and sterilization technologies. You will work with cross-functional teams to develop procedures, validate processes, and ensure ISO and FDA compliance throughout product lifecycles.

The role requires a bachelor’s degree in a scientific field with 3–5 years of related experience, or a MS with 0–2 years.