Manufacturing Associate (TEMPORARY)Location Novato, California
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.
Schedule NotesPositions may be 5 x 8 hour shift, 4 x 10 hour shift, or 3 x 12 hour shift. Operations are 24/7, so position may be for any one of several shift schedules. Shifts will be discussed at interviews. Please note candidates will receive weighted overtime for the 2nd shift (10% extra) and the 3rd shift (15% extra). Manufacturing Associates must have a degree or 1-2 years of manufacturing experience and the pay rate is firm at (USD)22.75 for all candidates to ensure internal pay equity.
Understanding of process theory and equipment operation
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated proficiency 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
QUALITY AND COMPLIANCE:
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
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to 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
- 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 a science-related area or engineering
• Associate’s degree in a science-related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.