Research Associate ILocation 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.
BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. BioMarin will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
The purpose of the job is to support the development and technical transfer of multiple products through various stages of development to manufacturing. This position will include working with new technologies such as gene therapy as well as protein therapeutics. The individual will be focusing on small-scale cell culture activities in the laboratory, developing processes in bench-top bioreactors as well as larger scale activities that may involve the transfer of processes to either Clinical of Commercial Manufacturing Facilities. The candidate ideally has experience in cell culture, bioprocessing, and more specifically, with bioreactor operations and harvest centrifugation/filtration processes. Experience with stem cell cultures, viral vectors or gene therapy is also preferred. Furthermore, the candidate would be expected to analyze culture samples via various analytical techniques. The individual must be competent with analysis and interpretation of data and comfortable using electronic lab notebook and other digital data capture systems.
Exercise limited discretion in the design and execution of cell culture experiments in shake flask as well as in bioreactors (mammalian batch, fed-batch or continuous processes).
Provide quantitative analysis of data and limited interpretation of results.
Write reports and present to group of >20 people
Evaluate moderately complex lab equipment.
Relate literature to current experimental work.May attend external training or seminars.Work on a wide range of processes of diverse scope.
0-2 years’ experience in process development or as a scientific research assistant
Require the following skills:
Cell culture, sterile technique
Analytical techniques: PCR, ddPCR, SDS- PAGE, Western blotting and ELISA
Familiarity with plate based assays, pipetting techniques
Strong verbal and written communication skills
Ability to use computers effectively as work requires
Ability to work effectively in groups
Bachelor's degree in a scientific discipline or equivalent with 2-5 years experience in process development or GMP manufacturing
Master's degree with 0-2 years’ experience
Bioreactors/Fermenters, centrifuges, filtration systems: setup, sterilization, maintenance, operation and troubleshooting
Analytical instruments and techniques (qPCR, ddPCR, ELISA, blood gas analyzer, chemical analyzers, osmometers, cell counter, plate readers, HPLCs): operation, maintenance and trouble-shooting; includes microscope: operation, photo-microscopy, cell counts
PC: Data acquisition, data analysis, word processing, statistical analysis, power point presentations, information searches, electronic lab notebooks
Members of Process Sciences, Manufacturing, Analytical Chemistry, and Research
Technical Representatives: from appropriate vendors/collaborators
Master's degree with 5+ years’ experience. Expert knowledge of GMP manufacturing and process transfer. Ability to resolve the most complex process development issues. Ability to take a leadership role in groups and to influence others effectively. Exercise significant technical discretion in the design and execution of a wide variety of complex experiments including quantitative data analysis and interpretation of results. Use results to design new experiments. Write complex protocols and technical reports. Evaluate very complex methods and technologies. Routinely identify new areas requiring evaluation. Exercise significant discretion in adapting complex processes and developing new processes. Identify and troubleshoot complex manufacturing problems. May lead process transfer and process validation activities. Evaluate complex lab equipment. Under direction, manage external contractors to develop processes or equipment. Make contributions to scientific publications and regulatory submissions. Participate in external seminars and conferences. Normally receives little supervision
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee will be working in a Biosafety Level 2 (BSL-2) designated laboratory. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
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.