QC In-Process ManagerLocation Novato, California Apply
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.
The QC In-Process Manager is responsible for the management of a GMP laboratory supporting biopharmaceutical manufacturing from cell culture up through final formulation. The position requires well developed supervisory, organizational, and project management skills. It is expected that the incumbent will supervise senior supervisory and lead staff and also work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, participating in the preparation of sections of INDs, NDAs, BLAs, and in PAIs, reviewing routine testing results, preparing protocols and reports, performing investigations, providing cGMP and technical development for the staff, and interfacing with other internal and partner departments relative to quality issues.
The QC In-Process Manager must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. The position requires some combination of thorough or working experience and knowledge within some of the following methodologies:
Bioburden, Endotoxin, Aseptic processing, Total Organic Carbon, Basic analytical skills including chromatographic based methods.
Knowledge in the following areas is beneficial but not required:
Enzyme kinetics; Spectrophotometry; Spectrofluorometry; Rapid microbial testing; PCR; Capillary and/or gel electrophoresis.
The QC In-Process Manager provides technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of biochemical and microbiological methods and routine In-Process testing..
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.