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Supervisor/Sr. Supervisor, QC Sample Management

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.

KEY RESPONSIBILITIES

QC Sample Management Supervisor/Sr. Supervisor will be responsible for oversight of Sample Management activities within Quality Control at the Novato Site.

Oversight responsibilities include, but not limited to the following:

  • Oversee coordination, receipt, accessioning, shipments, and inventory management of QC samples
  • Maintain Reserve/Retention Program
  • Maintains stability study and sample inventory management
  • Develop and maintain site sample management procedures
  • Manage preventative maintenance of critical temperature environments (CTEs)
  • Maintain audit readiness environment by organizing and cleanliness of sample storage locations
  • Develop and maintain site sample management procedures
  • Maintain department metrics as required
  • Performs deviations, change controls, and CAPAs when required
  • Collaborate with cross functional teams on key site and Global programs
  • Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary.
  • Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
  • Supervise, train, and provide leadership and technical expertise for direct reports as well as other members of the staff.
  • Lead and implement initiatives that add value to the QC and site operations

EDUCATION

  • M.S. with at least 2 years of experience in a relevant functional area (GMP laboratory experience).

Or

  • B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 4-6 years of experience in a relevant functional area (GMP laboratory experience).


EXPERIENCE REQUIRED

  • 4+ years in a cGMP laboratory, Quality Control experience preferred.
  • Demonstrate expertise with analytical methods used to assess biopharmaceutical products.
  • Ability to work independently, managing projects and meeting established timelines.
  • Comfortable with directing the activities of other staff members.
  • Demonstrates good interpersonal skills and leadership qualities.
  • Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred.
  • Experience with Microsoft Word and Excel are required.

SUPERVISOR RESPONSIBILITIES

  • Leads, Individual Contributor Technical roles, and Sample Coordinators report to the position.

COMPETENCIES

Behavioral

  • Accountability
  • Achieving Excellence
  • Communication
  • Courage / Challenge
  • Develop Self & Others
  • Judgement
  • Reliability
  • Teamwork


Technical

  • Technical Knowledge & Expertise                              
  • GMP Acumen
  • Critical Thinking & Evaluation                                    
  • Influencing                                                                
  • Organizational Awareness                                         
  • Performance Management                                        
  • Self-Knowledge                                                         
  • Talent Acquisition and Development    

Note: The QC Sample Coordinator Supervisor/Sr. Supervisor is an essential employee and may be required to work on BioMarin holidays and/or scheduled manufacturing shut down operations to support business needs.

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.

About our location

Novato

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