Research Associate 1Location Novato, California Workstyle Onsite Only Apply
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 selected candidate will work in the Analytical Sciences group to assist in the advancement of BioMarin’s therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible assay development, assay qualification, and characterization testing using routine and semi-routine analytical methods under limited supervision. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.
Primary responsibility is to support the Assay Services subgroup within Analytical Sciences.
- Performs analytical assays for samples within and outside the purview of assay services. including cell-based bioassays, ELISA, chromatography, PCR, and capillary electrophoresis.
- Provides major contributions to the evaluation of drug substance and drug product.
- Receives and records results for Assay Services in support of a variety of different groups including QC, MFG, Cell Culture PD, Purification PD and Formulation. Responsible for operational aspects of the laboratory through ordering, equipment maintenance and organization. This position will also record and interpret data generated and properly record into the company Electronic Notebook and/or Labware LIMS.
- Assist in planning and execution of relevant experiments to support development and qualification of analytical assays for gene therapy agents and biologics.
- Assists Scientists in the qualification of assay methods for transferring to the Quality Control Analytical and In-Process laboratories.
- Develops the capacity to troubleshoot assay methods and to suggest remedies for problems or improvements to the methods.
- Other duties as assigned.
- Experience in performing analytical methods including plate-based bioassays, HPLC, or PCR methods.
- Ability to analyze and interpret data.
- Good written and oral communication skills, with the ability to communicate complex information.
- Strong organizational skills with the ability to effectively multi-task and prioritize.
- Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.
- Experience working in a cross-functional environment.
- Experienced in method development, qualification, and transfer.
- Knowledge of biopharmaceutical development is a plus.
- Experience with mammalian cell culture is a plus
- Knowledge of GMP / GLP is a plus
Primarily a laboratory position; contact with chemicals is part of the job. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job.
- Bachelor’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 0 - 2+ years of experience in a Biologics or Pharmaceutical environment.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.