(CW) Manufacturing Associate (Temporary/Contract)
About The Position
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. This is a temporary/contract role with a specific shift schedule. The schedule will be from 6:00 pm to 7:00 am, with the first week covering Wednesday to Saturday, and the following week rotating to Wednesday to Friday. This means the schedule alternates each week between four and three nights.
Requirements
- Strong communication skills—verbal and written
- Ability to work in a team environment which includes good conflict resolution and collaboration
- Displays good initiative to identify areas for improvement and implement solutions
- Bachelor’s degree in science related area 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
- Understanding of process theory and equipment operation.
- Ability to 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 initiatives for process optimization.
- 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.
- Understanding of cGMPs as related to 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.
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What This Job Offers
Career Level
Entry Level
Education Level
Associate degree
