What are the responsibilities and job description for the Associate, Manufacturing (Day Shift) position at BioSpace?
Who We Are
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.
Summary
BioMarin’s Novato commercial manufacturing operations produce a variety of therapies using perfusion/fermentation based cell culture processes and multiple column purification systems. Under direction of the Supervisor, the Manufacturing Associate will be responsible for job functions that support activities for commercial manufacturing. 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, or 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 and potentially including weekends, off hours and holidays.
Responsibilities
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.
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.
Summary
BioMarin’s Novato commercial manufacturing operations produce a variety of therapies using perfusion/fermentation based cell culture processes and multiple column purification systems. Under direction of the Supervisor, the Manufacturing Associate will be responsible for job functions that support activities for commercial manufacturing. 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, or 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 and potentially 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
- 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
- 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
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.