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Scientist 2, Process Sciences

Location Novato, California
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. 

This position will utilize scientific and engineering principles to develop processes related to mammalian cell culture and oversee tech transfer activities to cGMP manufacturing sites. The individual will be leading a small team performing small- and pilot-scale cell culture activities in the laboratory towards development and optimization of processes suitable for manufacturing operations. The role will involve the transfer of processes to either Clinical or Commercial Manufacturing Facilities in Novato, CA, Shanbally, Ireland, or external Contract Manufacturing Organizations.

The candidate must have has experience in bioprocessing including scale-up and scale-down of key culture operations including operation of bench-scale and pilot scale bioreactors from 15mL up to 500L working volume and associated harvest centrifugation/filtration recovery equipment. Additional routine activities include thaw, expansion, and maintenance of cell cultures using a variety of culture platforms. Evaluation of new processing equipment and technologies together with internal colleagues and vendors is common. The candidate would be expected to analyze culture samples via various techniques involving 96-well plates, HPLCs/UPLCs, metabolite and blood gas analyzers, etc. Experience with cGMP, including operations and transfer, is strongly desired. 

This individual must be able to integrate experimental design expertise with technical knowledge, demonstrating an ability to drive and/or impact projects of a complex nature. The candidate should be capable of working independently with minimal supervision, but can work collaboratively on more complex projects and tasks as well as overseeing a group of one or more research associates.

The candidate will be involved in various projects that involve presenting data to collaborators and will therefore be routinely expected to write, review, and approve memos, protocols and reports by organizing data and observations. The candidate would be expected to train, mentor, and/or supervise fellow employees as appropriate to support their professional development and contribution to the programs. The candidate should also expect hands-on training time within manufacturing facilities. 

Education and experience expectations: Ph.D in Biochemistry, Biology, Chemical/Bioengineering or other related scientific discipline plus at least 2 years of relevant biopharmaceutical experience, (Master's degree plus at least 8 years, Bachelor's degree plus at least 10 years).

Work Environment/Physical Demands: Must work closely and productively with fellow members of Process Sciences and related BioMarin groups. The employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually modest. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Employee may be asked to move or lift heavy objects up to 50 lb with assistance. The employee may be asked to work in GMP facilities for sake of technical transfer and manufacturing support activities and comply with the work requirements and procedures of these specialized areas.

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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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