Sr. Supervisor, QC ProductLocation Novato, California
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.
The Quality Control Analytical Sr. Supervisor/Supervisor is responsible for the biological, biochemical and chemical evaluation of stability, formulated bulk drug substance and drug product release testing.
The Supervisor will be responsible for supervising and conducting both stability and drug release testing under cGMP guidelines. Functional activities for this position could include: supervising at least one analyst, Reviewing a wide variety of tests/results for stability program testing, formulation studies, method validations, SOP development, and reagent preparation.
This position requires experience with HPLC, gel electrophoresis, enzyme reactions, spectrophotometry and spectrofluorometry. Work assignments will encompass activities from semi-routine to complex in nature with the ability to recognize deviations from the accepted practice. The incumbent will be responsible for the timely completion of assignments and for coordinating or performing laboratory investigations and assay troubleshooting.
Knowledge of cGMP is required and a significant component of the position is to coordinate the compilation of test results for various purposes, including preparation of Certificates of Analysis, Stability Reports, and documentation in support of regulatory filings.Candidate should be able to work independently with some to minimal supervision and be able to deal with multiple tasks.
Candidate should possess good interpersonal skills and leadership qualities. Excellent organization, written and verbal communication skills are essential. Proficient with various software programs including, but not limited to, Word, Excel, Access and PowerPoint. Demonstrated expertise in one or more functional areas including microbiological or analytical in-process methods is an advantage.
- Scheduling and oversight of method transfers, drug substance and drug product lot release, and stability testing to meet timelines and organizational goals. The supervisor should be cognizant of business needs.
- Supervise, train, and provide leadership and technical expertise for direct reports as well as other members of the staff.
- Evaluate the accuracy of data and trend results and provide written reports based on these results.
- Perform routine and non-routine studies.
- Assist in the development of procedures and laboratory investigations.
- Supervise personnel assigned to the supervisor, as well as scheduling and daily operations of the laboratory in general.
- Maintain and control laboratory inventories.
- Write procedures
- Provide for the safety of his/her employees.
- Provide laboratory support for inspection readiness.
- Participate in the preparation of sections of INDs, NDAs, BLAs and other regulatory filings.
- Knowledgeable concerning 21CFR, USP, EP and ICH regulatory guidelines.
- Experience in quality control practices and knowledge of cGMP required.
- Accomplish most tasks with little to no supervision.
- Demonstrates good interpersonal skills and leadership qualities.
- Computer literacy is required.
- Experience with Microsoft Word, Excel, PowerPoint are required.
- Proficient in written and verbal communication skills.
- At least two years of Supervisory experience
- Separation methods experience (i.e. HPLC, CE, SDS-PAGE)
B.S. /B.A. degree in science and 4+ years of experience in a pharmaceutical laboratory that includes some supervisory experience. M.S. degree with at least 2 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.