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Bioprocess Specialist, Manufacturing

Company: BioMarin Pharmaceutical Inc.
Location: Novato
Posted on: November 26, 2022

Job Description:

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. Manufacturing BioProcess Specialist (BPS)ROLE DESCRIPTION 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 individuals build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, procure the needed goods and services to support manufacturing, and coordinate the worldwide movement of our drugs to patients.As a member of a Process Team, the Manufacturing BioProcess Specialist (BPS) will work closely with representatives from Manufacturing, Manufacturing Science & Technology, Engineering, and Quality as well as Automation, Validation, and other supporting Organizations in support of day to day plant operations. With a focus on execution of operations, the Manufacturing BPS will investigate deviation incidents, identify and implement corrective or preventive actions, and execute continuous improvement projects. As a member of a Process Team, the Manufacturing BPS will influence technical strategy and project prioritization.The Manufacturing BPS role is a front-line Subject Matter Expert (SME) for the operational execution of a defined manufacturing process. As a SME, the Manufacturing BPS is expected to know how manufacturing systems (procedures, batch records, automation, equipment, biological processes) work in conjunction with operations floor staff to deliver quality product supply while using creativity and technical acumen to troubleshoot and develop plans to transform and mature those systems. RESPONSIBILITIESAs a member of a Process Team, the Manufacturing BPS is responsible for the operations execution of a defined manufacturing process; Upstream or Downstream operations of one of BioMarin's products. This includes the following activities:

  • Respond to, and/or troubleshoot, operational issues and drive robust and compliant processes
  • In accordance with BioMarin policies and procedures, regulatory requirements, guidelines, and recommendations:
  • Investigate, manage, and own deviations in the Quality Management System as necessary to support the Process Teams
    • Use root cause analysis techniques to identify true root cause of incidents and determine appropriate Corrective and/or Preventive Actions
    • Manage and own related Change Records
    • Collaborate in a matrixed organization to contribute to comprehensive implementation plans for investigations and changes
    • Use defined metric processes to recognize potential deviations and escalate to MFG Management and QA
    • Drive continuous improvement initiatives
    • Develop and deploy GMP and/or Manufacturing-related training to Manufacturing floor staff
    • Write, modify, and implement GMP Procedures and Batch Records EDUCATION AND EXPERIENCE
      • Required: Relevant experience in pharmaceutical or biopharmaceutical manufacturing
        • 4+ years' experience in pharmaceutical or biopharmaceutical manufacturing with a BA or BS Degree in biological science or engineeringor
          • 2+ years' experience in pharmaceutical or biopharmaceutical manufacturing with a MS degree in biological science or engineeringREQUIRED QUALIFICATIONS
            • Operational knowledge of process automation and associated equipment
            • Familiarity with the underlying scientific principles that drive biologic protein manufacturing
            • Understanding of cGMP guidelines pertaining to biopharmaceutical processing and GMP compliance
            • Ability and willingness to work well in a team environment and independently with minimal guidance
            • Demonstrated Ability to:
              • Solve complex technical problems
              • Handle multiple tasks concurrently and be flexible and adaptable as needed, to support operations in a dynamic environment and to support the Process Team goals
              • Meet deadlines and drive projects without direct authority as the primary change agent
              • Strong technical writing abilityPREFERRED QUALIFICATIONS
                • Demonstrated ability to coach others to drive for results; guide team members in a way which best suits their work style
                • Effective at exploring alternatives to reach outcomes which gain the support and acceptance of all parties
                • Skilled at asking penetrating questions to define the problem accurately
                • Project Management experience
                • Operational Excellence and/or Six Sigma experience 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.

Keywords: BioMarin Pharmaceutical Inc., Novato , Bioprocess Specialist, Manufacturing, Other , Novato, California

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