Specialist 1, Pilot Plant ManufacturingLocation Novato, California Workstyle Onsite Only Apply
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 bioprocess specialist 1 (BPS1) in Gene Therapy Pilot Plant is a dynamic role that focuses on both engagement of external pilot plant customers and support of internal pilot plant operations. The BPS will work closely with technical development, quality, and engineering to support transfer of early phase gene therapy products to the pilot plant. The BPS will play a key role in supporting floor operations during manufacturing campaigns including triage and troubleshooting of technical issues, quality record ownership, training on new manufacturing equipment/processes, and supporting operational readiness.
• Physical presence on the floor for critical process transfer activities.
• Facilitation of technical troubleshooting with an emphasis on driving resolution
• Ownership of deviations and change controls.
• Authorship and/or review of manufacturing SOP’s, batch records, and technical transfer documentation
• Compilation and presentation of manufacturing data and summary reports.
Note: The position may require off hours support as needed. Flexible scheduling including remote work is possible when pilot plant not in production.
• Strong knowledge of biologics manufacturing, gene therapy experience is preferred.
• Knowledge of quality systems, good manufacturing practices, and fundamentals of quality assurance.
• Demonstrated proficiency navigating technical challenges.
• Experience working cross-functionally and managing complex projects.
• Independent ownership of complex projects
• Facilitation of technical discussions and forums.
• Clear communication to stakeholders and functional managers via written and verbal updates
• Lives department values and sets the standards for others to operate
• Fosters an environment of compliance, work ethic, and development
EDUCATION, EXPERIENCE AND EXPERTISE
• B.S. degree in Life Sciences, Engineering, Applied Physics, etc.
• 1-3 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
WORK ENVIRONMENT/PHYSICAL DEMANDS
• 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 occasional off-hours and weekend support
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.
In the U.S., the salary range for this position is $ 62,600 to $ 93,800 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.