Manufacturing Associate (Night Shift)

Location:  Novato, California Category: Manufacturing

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Description

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 Position
 
SUMMARY 
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 individuals 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.
 
RESPONSIBILITIES 
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 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.
 
EXPERIENCE
 
Required Skills:
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
 
Desired Skills:
1-2 years of experience in a GMP and Manufacturing field
 
EDUCATION
BA/BS preferred not required, Biotech certificate  
 
EQUIPMENT 
Chromatography skids, TFF skids, Buffer tanks, Lab washers and Autoclaves 
 
CONTACTS 
Manufacturing Management  
 
SHIFT DETAILS
 
Position will be for the Back half Graves Wed/Thurs-Sat 6pm-7am. Alternating Wed.
  
ONSITE, REMOTE, OR FLEXIBLE 
Onsite only  
 
WORK ENVIRONMENT/PHYSICAL DEMANDS 
  • Consists of strenuous, repetitive work. The following list of physical movements maybe used daily: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands and tools. 
  • Independently can regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. 
  • May require work around loud equipment. 
  • The use of personal protective equipment will be required. 
  • Requires various shift based work and off hours 
TRAVEL REQUIRED 
NA 


Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Who We Are

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.

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