Manufacturing Associate/Sr. Manufacturing Associate (Night Shift)
About The Position
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. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Manufacturing Associate / Sr. Manufacturing Associate Position
Requirements
- Associate: 0-2 years experience in Manufacturing
- Able to read and understand SOP’s & BRs
- Able to multi-task when needed
- Able to run high end equipment and machinery
- Able to work safely in a GMP laboratory
- Sr Associate: 2-4 years experience in Manufacturing
Nice To Haves
- 1-2 years of experience in a GMP and Manufacturing field
- BA/BS preferred not required, Biotech certificate
Responsibilities
- Understanding of process theory and equipment operation
- Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with a broad understanding of scientific , compliance, and technical components
- Support initiatives for process optimization
- Identify and elevate processing issues and support solutions
- Demonstrated 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
- Understanding of cGMPs as related to Clinical and/or Commercial Operations
- Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
- Ability to participate on projects and contribute to outcomes
- Capability to learn and support new business systems (Track wise, ERP, etc.)
- Support trending of defined department metrics
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
