Biotech GMP Manufacturing Technician

biomarin; Novato (CA); On-site; USD 60,000 - 95,000; Full time

Job summary

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. BioMarin’s Technical Operations group builds and maintains manufacturing processes, ensuring quality and regulatory compliance for clinical and commercial drug substances.

We are seeking candidates with a science or engineering background and hands-on experience in biotech manufacturing, ready to contribute to cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor’s degree in a science-related field or engineering.
• Associate’s degree in science-related area or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.

Responsibilities

• Understand process theory and equipment operation; learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance; support process optimization initiatives; identify and elevate processing issues and support solutions; gain experience with automation systems (LIMS, MES, PI, etc.).
• Provide feedback and/or suggested changes to operational procedures; assist in the incorporation of new technologies, practices, and standards into procedures; capable of writing and reviewing process documents.
• Understand cGMPs as related to Commercial Operations; utilize quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Participate on projects and contribute to outcomes; learn and support new business systems (Track wise, ERP, etc.); support trending of defined department metrics.

Skills

Strong verbal communication

Strong written communication

Teamwork

Initiative

Education

Bachelor’s degree in science/engineering

Associate’s degree or biotech certificate + 2+ years experience

Tools

LIMS

MES

PI

TrackWise

ERP

Job description

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. BioMarin’s Technical Operations group builds and maintains manufacturing processes, ensuring quality and regulatory compliance for clinical and commercial drug substances.

We are seeking candidates with a science or engineering background and hands-on experience in biotech manufacturing, ready to contribute to cross-functional teams in a fast-paced environment.