Sr. Scientist, MSAT Bacterial Fermentation
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 The Manufacturing Sciences and Technology (MSAT) Fermentation Scientist requires a high level of technical expertise in the production of biologics from the bench scale through large scale commercial manufacturing for bacterial based fermentation processes. The successful candidate will play a key role in ensuring BioMarin's commercial bacterial fermentation processes remain in a state of control by leading process improvement initiatives, process characterization studies, as well as spearheading investigations when manufacturing issues occur. The individual will also be responsible for routine monitoring of processes and providing on-the-floor manufacturing support, as needed. In addition to on-the-floor support, the successful candidate will be responsible for planning and execution of small scale lab experiments in support of process validation, process characterization, and continuous process improvements and troubleshooting. The candidate must have a high degree of familiarity with Quality and Regulatory requirements related to the cGMP manufacture of biologics. This position involves close collaboration with process development, analytical, manufacturing, quality, and regulatory groups. The candidate must be a strong individual contributor able to think critically and work independently, while also contributing effectively within a team environment. Management and leadership skills along with excellent interpersonal and communication skills are highly desirable. The Fermentation Scientist must embrace the importance of being organized, proactive, and able to demonstrate independence and leadership. RESPONSIBILITIES
Provide technical support for ongoing fermentation processes including the ability to lead or participate in the diagnosis and resolution of production problems.
Design and execute experiments in support of process characterization, validation and continuous process improvement studies.
Provide Manufacturing with critical information necessary to maintain consistent product supply, now and into the future.
Participate in monitoring commercial production processes.
Establish and maintain scaled-down models of bacterial fermentation processes.
Develop and/or test the feasibility of new manufacturing technologies.
Interface with Manufacturing, Quality, Regulatory and Process Development to facilitate efficient technology transfer of new production processes and change control.
EXPERIENCE Required Skills:
Demonstrated skill in bacterial fermentation techniques.
Understands quality and regulatory aspects of cGMP production of biologics.
Experienced in the operation of bacterial fermentors at lab, pilot and commercial scales.
Extensive knowledge of cGMP and large-scale manufacturing equipment and practices.
Demonstrated skill in leading teams tasked with resolving production related issues.
Statistical design of experiments (DoE) experience
Multivariate Data Analysis (MVDA) experience, including familiarity of PCA, Discriminant Analysis and PLS.
EDUCATION Bachelor's degree in Biochemical Engineering or a related scientific discipline with 10 years experience in process development or cGMP manufacturing; or Master's degree in a scientific discipline or equivalent with 8 years experience in process development or cGMP manufacturing. Ph. D. with 3 years experience in process development or cGMP manufacturing.
SUPERVISOR RESPONSIBILITY Depending on experience 0 - 2 Research Associates or Process Engineers #LI-SM1 ~BIO