Scientist 2/Sr. Scientist 1
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 We are looking for a highly-motivated team member to be a key contributor in Manufacturing Science and Technology (MSAT) Downstream Purification group responsible for improving process understanding and supporting manufacturing investigations of commercial and late stage product processes. RESPONSIBILITIES Perform scale-down or at scale downstream process troubleshooting, summarize findings, and author technical reports/memos Design and execute experimental plans to support functions associated with process variability reduction, product quality improvement, and process streamlining Conduct root cause analysis, FMEA, and develop corrective and preventive actions to reduce likelihood of recurrence Perform analytical techniques and instrumentation, such as high performance liquid chromatography (HPLC), ion chromatography, electrochromatography and spectroscopy Assist with evaluation of downstream process changes Mentor and provide guidance to Research Associates Communicate with other departments and all stakeholders to drive investigation completion Participate and present data as a member of MSAT Participate in scientific meetings and produces original peer-reviewed publications. Keep current with advances in technologies related to bioprocessing
EXPERIENCE Required Skills: Extensive knowledge of chromatography techniques required Hands-on experience on GE AKTA systems, depth filtration, Tangential Flow Filtration (TFF), membrane chromatography, H/UPLC, and analysis techniques Knowledge of commercial biologic manufacturing operations, cGMP's, validation, and regulatory affairs Maintain and organize accurate records Excellent verbal and written communication skills
Desired Skills: Working knowledge of continuous bioprocessing a plus Basic formulation knowledge a plus
EDUCATION PhD in chemistry, chemical engineering, biochemistry or biology or equivalent and 2-5 years experience in biologic downstream process development MS in chemistry, chemical engineering, biochemistry or biology or equivalent and 8-10 years experience in biologic downstream process development BS in chemistry, chemical engineering, biochemistry or biology or equivalent and 12 years experience in biologic downstream process development
CONTACTS Other associates, assistants, scientists, and senior scientists in Manufacturing Sciences, Analytical Chemistry, Process Development and Quality Control. SUPERVISOR RESPONSIBILITY May be responsible for supervision of Research Associates #LI-SM1 ~BIO