QC Microbiology Supervisor - 2nd shift

Location:  Novato, California Category: Quality

Description

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.

NOTE: This position is for Sunday through Thursday Swing Shift (1400-2230).

SUMMARY

BioMarin is seeking a QC Microbiology Supervisor for the QC Viral Vector Microbiology Group. The QC Supervisor will be responsible for the biological, biochemical and chemical evaluation of environmental monitoring sampling, testing of facilities and utilities and in-process samples.  This position could also serve as backup for the microbial identification laboratory. 

The candidate will be responsible for overseeing the biological, biochemical and chemical evaluation of environmental monitoring sampling and testing of facilities, utilities and in-process samples under cGMP guidelines. This person will provide training and technical leadership to less experienced staff.

This position requires experience with microbiology aseptic techniques and analytical methods. Work assignments will encompass activities from semi-routine to complex in nature with the ability to recognize deviations from the accepted practice.   The candidate will be responsible for completing assignments timely, for troubleshooting, and for follow-up on any testing issues.  Knowledge of cGMP is required. 

Candidate should be able to work independently with minimal supervision and be able to deal with multiple tasks.  Candidate should possess good interpersonal and strong critical thinking/problem solving skills and able to lead others by example.  Excellent organization, written and verbal communication skills are a must.  Proficient with various software programs including, but not limited to, Word, Excel, Access, and PowerPoint.  Demonstrated expertise in functional area including microbiological or analytical in-process methods. The successful candidate will have a strong microbiology background. Previous supervisory experience preferred.

RESPONSIBILITIES

  1. Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.  Efforts include the resolution of MODA/LIMS discrepancies and approval of MODA/LIMS entries.
  2. Mentor, train, and provide leadership and technical expertise for several analysts.
  3. Evaluate the accuracy of data and trend results.  
  4. Manage contract lab tests and review of data from these labs.
  5. Perform routine and non-routine studies.
  6. Assist in the development of procedures and troubleshoot assays.
  7. Assist in the supervision of personnel, scheduling and daily operations of the laboratory.
  8. Maintain and control laboratory inventories.
  9. Validate methods and laboratory equipment and write procedures.
  10. Provide for the safety of the employees.
  11. Provide laboratory support for inspection readiness.
  12. Work with Project Teams to drive timelines and efforts to the common goal.
  13. Knowledgeable concerning 21CFR, USP, EP, and ICH regulatory guidelines
  14. Fill Finish, method validation, sterility and/or mycoplasma testing experience is a plus.

SCOPE

Effective performance ensures that the Quality Control department and the company achieve the annual objectives with respect to the established goals and budget.  Maintains the laboratory in a productive and compliant status.

EDUCATION

B.S./B.A. degree in a biological or biochemical science and  at least 8 years of experience in a pharmaceutical laboratory (at least 2 years in QC) that includes some supervisory experience.  M.S. degree with at least 4 years of GMP laboratory experience.
  
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.