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Supervisor, Downstream Purification

Job in Novato, Marin County, California, 94949, USA
Listing for: BioSpace
Full Time position
Listed on 2026-07-15
Job specializations:
  • Quality Assurance - QA/QC
    Production QC/QA
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below

Bio Marin’s Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market. Engineers, technicians, scientists and support staff build and maintain cutting‑edge manufacturing processes, provide quality assurance and control to meet regulatory standards, and procure the goods and services that support manufacturing and coordination of drugs worldwide.

Join our team and make a meaningful impact on patients’ lives.

Responsibilities
  • Accountable for daily operations in area, requiring effective communication to make appropriate decisions, troubleshoot, and schedule adherence with minimal oversight.
  • Accomplishes tasks through direct and effective coordination.
  • Provides direction and hands‑on training for staff.
  • Manages staff.
  • Lives department values and sets the standards for others.
  • Fosters an environment of compliance, strong work ethic, and ongoing learning.
Contribution
  • Ability to take responsibility for complex projects.
  • Effective interaction with peers across manufacturing to create alignment and improvement.
  • Partners with support groups (Facilities, Validation, MSAT, Quality) to complete scheduled activities.
Process Knowledge
  • Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance.
  • Ability to troubleshoot, identify issues and support resolutions with technical groups.
  • Required to perform ongoing operational tasks in respective work area.
  • Uses scientific thinking and decision making in daily work.
Technical Competency
  • Proven experience with relevant process, theory, and equipment.
  • Experience with process automation and functionality.
  • Assists with review and approval of documentation including batch records and logbooks.
  • Provides feedback and or suggested changes to operational procedures.
  • Assists in the incorporation of new technologies, practices and standards into procedures.
  • Capable of writing and reviewing process documents.
Quality and Compliance
  • Complete understanding and adherence to cGMP's as related to commercial operations.
  • Initiates and owns required corrective and preventative actions and leads change control actions.
  • Supports the closure of manufacturing discrepancies and change requests.
  • Current understanding of FDA and EMEA guidelines and cGMP's for manufactured drug products.
Business
  • Experience with business systems (process historian, LIMS, Trackwise, ERP, MES).
  • Supports trending and communication of defined department metrics.
  • Identify and drive opportunities for process and business optimization.
  • Translates company and department goals into actionable objectives for self and staff.
  • Other duties as assigned.
Qualifications
  • B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
  • 4+ years of directly related industry experience, including at least 2+ years with proven leadership role.
  • Ability to independently manage work, actions and expectations is essential.
Night Shift Details
  • Sun‑Tues, alt Wed, 18:00–07:00.
  • MFG area is specific to Drug Substance Purification.
  • 100% time on‑site.
  • Shift differential pay for any off‑hour shifts including swing and grave.

All incoming employees must be vaccinated for COVID‑19 unless they have a medical or religious reason that prohibits vaccinations.

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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