Bioprocess Specialist 1, Gene Therapy Pilot Plant

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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.

SUMMARY

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.

RESPONSIBILITIES

Manufacturing Support

• 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.

Technical Expertise

• 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.

Contribution

• 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

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.