
Posted 4 days ago
Manufacturing Associate
BioMarin
Requirements
Bachelor's degree in science or engineering, OR Associate's degree in science with 2+ years biotech experience, Understanding of cGMPs, Ability to lift 25 pounds, Ability to work shift-based hours
Skills
GMPBiotechnologyMammalian Cell Culture
About the role
Responsibilities
- Support biopharmaceutical manufacturing processes including mammalian cell culture, protein purification, and formulation of bulk drug substance
- Execute technical operations such as depth filtration, tangential flow filtration, column chromatography, and centrifugation
- Maintain technical documentation by writing and reviewing process documents and providing feedback on operational procedures
- Ensure compliance with cGMP standards and utilize quality systems for deviations, CAPAs, and change requests
- Identify and escalate processing issues and support initiatives for process optimization
- Utilize automation and business systems including LIMS, MES, and ERP
Requirements
- Bachelor's degree in a science-related area or engineering
- OR an Associate's degree in a science-related area or Biotech certificate with 2+ years of experience in a biotech manufacturing or regulated environment
- Strong understanding of cGMPs as they relate to commercial operations
- Ability to work shift-based hours (including Sunday-Tuesday/alternating Saturdays, 1800-0700)
- Physical ability to perform strenuous, repetitive work, including bending, reaching, climbing, and kneeling
- Ability to independently lift, dispense, push, or pull items weighing an average of 25 pounds
Preferred Qualifications
- Experience with automation systems such as LIMS, MES, or PI
- Familiarity with quality management software like Trackwise
About the Company
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Our manufacturing and process development teams manage the production of transformative therapies for clinical trials and commercial markets.
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BioMarin · Novato
