Manufacturing Associate I
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- May 28, 2021
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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.
Duties
Swing Shift Monday - Friday 2pm-11pm
Under direction of the Supervisor, the Manufacturing Associate will be responsible for job functions that support activities for manufacturing. The Associate is responsible for working on a shift with 3 – 8 peers with responsibilities of supporting implementation of new equipment, preparing filling and packaging materials, setting up the manufacturing line, sampling for QC testing, teardown and cleaning of equipment, managing raw material inventory, operating process equipment, visual inspection and packaging of drug product containers. In addition the manufacturing associate will be expected to operate in compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position will require shift work and potentially include weekends, off hours, holidays, and overtime.
- Understanding of process theory and operation of equipment including isolators, biological safety cabinets, automated filling/stoppering/capping machine, ultrasonic bath, autoclave, and filter integrity testers.
- Ability to learn biopharmaceutical manufacturing processes including Aseptic Filling, Visual Inspection and Packaging, Sterile Filtration, Bio-process containers and Single Use Systems, and Lean manufacturing and 5S.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- Support initiatives for implementation of new equipment and 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 procedure.
- Support trending of defined department metrics.
- Crosstrain to support other manufacturing groups as needed.
Skills
- Capable of writing and reviewing process documents.
- Understanding of cGMPs as related to Manufacturing 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 (TrackWise, ERP, etc.).
Specific vision abilities by this job include close vision, depth perception and ability to adjust focus
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements maybe 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
Bachelor’s degree in science related area or engineering
or
Associate’s degree in 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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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