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QC Product Lead (Separations)

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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 of Position

 The Quality Control Product Separations Lead reports to Quality Control Supervisor and/or manager. Responsible for providing leadership, vision and daily test guidance to the Separations team in all areas of logistics functions but not limited to Separation team, QC sub-teams, maintenance, and safety. Performs testing and reports results to ensure a consistent and high level of quality and compliance. Performs secondary review of results to ensure a consistent and high level of quality and compliance. May perform supervisory role to technician level staff. Resolves problems requiring in depth knowledge of equipment and chromatography systems. Mentor and provide guidance for junior staff. Good record keeping, organizational, written and verbal communication skills.

The specific responsibility of the position will include
  • Review logbooks but not limited to quality records for review of completeness, accuracy, and consistency to meet the compliance requirement and/or specification.
  • Perform secondary review of data and results and perform laboratory investigations when necessary with supervision of laboratory supervisor /Manager.
  • May supervise technician level staff, responsible for weekly time sheets and training schedule.
  • Participate in team meetings but not limited to preparation and presenting meeting materials.
  • Develop new approaches to solve problems identified during quality assurance activities.  
  • Assist in the continuous growth of the Quality Department.
  • Lead, mentor, and coach junior level analysts by promoting a culture of quality awareness.
  • Perform quality testing and other duties as assigned.
  • Adhere to department goals and self-promoting to drive performances.      
  • Ensure operation personnel comply with government and industry quality assurance codes and standards.
  • Maintains the laboratory in an inspection-ready state. Ensures other routine laboratory functions/chores/safety for the QC laboratory are met to meet business needs.
  • Participate in audits, inspections, to ensure compliance with policies and procedures, and implements corrective actions as required.
  • Familiars with regulations cGMP, 21CFR, USP, EP, and ICH regulatory requirements.
  • Holds self and others responsible to abide by department and company policies, procedures, and best practices. Is responsible for setting a good example for more junior analysts in the department.  

Education and experience

 B.S./B.A. in Science (major in biology-biochemistry-chemistry) with 5+ years of relevant laboratory experience or A.S. with at least 8 years of relevant laboratory experience is desired.

3+ years in a cGMP/GLP laboratory; quality control experience is preferred.

Ability to follow written instructions and to perform tasks with direct or minimal supervision.

Demonstrate strong leadership skills through past work history.

Familiarity with use of a computer: e.g., Proficient in Empower, Chromeleon, Windows, Microsoft Word, Excel, LabWare LIMS, CMMS, and TrackWise.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, 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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