Associate, Manufacturing (Day Shift)

Location:  Novato, California Category: Manufacturing

Description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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.

The Associate is responsible for working on a shift with 6 – 10 peers with responsibilities of preparing large scale solutions (buffers and media), managing raw material inventory, and operating process equipment in Upstream or Downstream areas while supporting daily operations.  Additional responsibilities include ensuring 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 including weekends, off hours and holidays.
 
RESPONSIBILITIES 
  • Operate large scale bioprocess equipment for the Cell Culture, Purification, or Buffer and Media processing 
  • Perform all aspects of processing with a broad understanding of science, compliance, and technical aspect 
  • Display competency with process equipment and automated control systems 
  • Perform cleaning and sterilization of parts and equipment used with manufacturing process 
  • Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations. 
  • Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position 
  • Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing 
SKILLS
  • Strong communication skills—verbal and write
  • 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
EDUCATION 
  • Bachelor’s degree in science related area or engineering or associate degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry 
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 
EXPERIENCE
2 years of industry experience.
 
EDUCATION
4 years of college or 2 years of biotechnology program.
 
EQUIPMENT 
Autoclave, lab washer, bioreactors. Automated CIP Skids, Bio Welders, Ultra sonic baths, Stainless Steel Vessels and Analytical Benchtop equipment.
 
CONTACTS 
Teammates on shift and Upstream Process Team and Personnel from support departments.
 
SHIFT DETAILS 
Rotating 12hr shift. Hours: 6:00am – 7:00pm / Days: Thursdays-Saturdays with alternating Wednesdays. (Back Half of the week)
 
ONSITE, REMOTE, OR FLEXIBLE 
Onsite Only
 
TRAVEL REQUIRED 
No Travel required.



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.