Specialist 1, Pilot Plant Manufacturing

Location:  Novato, California Category: Technical Development


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.

The Pilot Plant Manufacturing Specialist I is required to have basic process and equipment knowledge related to biopharmaceutical manufacturing. The position requires self-motivation, excellent communication, and strong trouble-shooting skills. The Pilot Plant Manufacturing Specialist I will be acquainted with many manufacturing processes and be able to perform multiple operations with proper training and under appropriate level of supervision. The Pilot Plant Manufacturing Specialist I will be responsible for planning, and execution of manufacturing activities with primary duties occurring on the manufacturing floor.

The position is roughly equivalent to manufacturing area/Sr Associate, or technical development/research associate I.

The position reports to the manufacturing supervisor or manager and requires shift work with a variable schedule, potentially including weekends, off hours, and holidays.

• Responsible for performing daily operations on the production floor, including training, and troubleshooting to ensure that all operations are completed safely and successfully.
• Perform operational and production tasks in respective work area
• Expected to be on the MFG floor performing operations minimum 80% of the time during campaign
• Supports startup logistics, technical transfer, and changeover process between campaigns.
• Expected to have opportunity to learn and contribute in process development laboratories, including but not limited to the following activities:
o Buffer and media preparation
o Small-scale cell culture or purification process development experiments
o Perform associated analytical assays
o Diligently document the results
o Present results and conclusions in group and department meetings
Technical Expertise
• On-the-floor equipment and process Subject Matter Expert (SME)
• Assist with recipe development, design, and programming.
• Assist with equipment maintenance and CMMS management
• Author minor changes Standard Operating Procedures and Batch Records
• First point of contact for equipment and process troubleshooting
• Works as an on-the-floor SME for many electronic systems including CMMS, JIRA, LIMS, PI, and SCADA
• Interface with Process Development to assist in data collection and provide operational feedback.

Manufacturing Support

• On-the-floor contact for process changes and new equipment implementation
• May assist with initiating process deviations and gathering initial details relevant to the event.

• Ability to assist with moderate level projects
• Effective interaction with peer specialists within the pilot plant core team to effectively carryout the objectives of the pilot plant.
• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities
• Involved in technical decision-making of the process with the pilot plant leadership
• Lives department values and sets the standards for others to operate
• Fosters an environment of compliance, work ethics and development
• Identify and drive opportunities for process optimization

• B.S. degree in Life Sciences, Engineering, Applied Physics, etc.
• 1-2 years of relevant industry experience
• Acceptable equivalent combination of education and experience will be considered
• Demonstrated technical expertise
• Knowledge in all aspects of process theory, equipment, and compliance preferred
• Working knowledge of process automation, associated process equipment, and relevant technical documentation
• Proven technical and communication skills
• 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 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.