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. Come join our team and make a meaningful impact on patients’ lives. KEY RESPONSIBILITIES
• Process Knowledge
o Understanding of process theory and equipment operation
o 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/or fill finish procedures; and perform all aspects with a broad understanding of scientific , compliance, and technical components
o Support initiatives for process optimization
o Identify and elevate processing issues and support solutions
o Demonstrated experience with automation systems (LIMS, MES, PI, etc.)• Technical Documentation
o Provide feedback and/or suggested changes to operational procedures
o Assist in the incorporation of new technologies, practices and standards into procedures
o Capable of writing and reviewing process documents
• Quality and Compliance
o Understanding of cGMPs as related to Clinical and/or Commercial Operations
o Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)• Business
o Ability to participate on projects and contribute to outcomes
o Capability to learn and support new business systems (Track wise, ERP, etc.)
o Support trending of defined department metrics
• Other duties as assigned.
• 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
Overnight shift hours are Su-Thu 2200-0700.**We do provide Shift Differential pay for any off-hour shifts including Swing and Grave**
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.