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Bioprocess Specialist, Manufacturing

Location Novato, California

Bioprocess Specialist, Manufacturing

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 Organizationsin 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 aProcess 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 manufacturingprocess. 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; 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 deviationsin 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
  • Manageand 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 ofcGMP 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 exploringalternatives to reachoutcomeswhichgain thesupportandacceptanceofall 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. 

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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