R&D Biochemistry & Microbiology Scientist II

Socket.dev

Irvine (CA)

On-site

USD 85,000 - 120,000

Full time

5 days ago

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Job summary

ASP is seeking a Scientist II in R&D Biochemistry and Microbiology to support new product development and life cycle management for ASP products. The role requires collaboration with R&D, Operations and QA to develop and validate biosciences processes and ensure compliant manufacturing and testing.

The position emphasizes biochemical and microbiological analyses, microbial fermentation support, and design changes to ensure robust processes meeting CTQs, ISO and FDA expectations, with a

Qualifications

Degree(s) in a scientific discipline with 3–5 years in Medical Device or GxP-regulated industry.
Experience with IQ/OQ/PQ and PV processes is preferred.
Strong analytical and problem-solving skills; able to work independently or in a team.

Responsibilities

Support NPD and life cycle management for ASP products; assist in BI production and related analyses.
Conduct biochemical and microbiological analyses, including enzyme analyses and fermentation development.
Assist design changes, validations, testing, and supplier process robustness.
Collaborate with cross-functional teams (R&D, Operations, QA) and communicate issues to management.

Skills

Biochemistry

Microbiology

Six Sigma

Lean

Analytical methods

Process development

QA / GMP knowledge

Education

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

MS in Microbiology or equivalent

Job description

The position emphasizes biochemical and microbiological analyses, microbial fermentation support, and design changes to ensure robust processes meeting CTQs, ISO and FDA expectations, with a

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