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Bioprocess Specialist 1, Manufacturing

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Nov 24, 2023

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Job Details

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.

As a member of a Process Team, the Manufacturing BioProcess Specialist 1 (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 1 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.

RESPONSIBILITIES

As a member of a Process Team, the Manufacturing BPS is responsible for the operations execution of a defined manufacturing process; 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 engineering

OR

  • 2+ years’ experience in pharmaceutical or biopharmaceutical manufacturing with a MS degree in biological science or engineering

REQUIRED 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 ability

PREFERRED 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



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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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