Research Associate 2Location 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 routine testing subgroup (RTG) within Analytical Sciences.
Responsibilities include, but are not limited to the following:
- Performs analytical assays for samples within and outside the purview of RTG including cell-based bioassays, ELISA, chromatography, PCR, and capillary electrophoresis.
- Contributes to the release and stability evaluation of drug substance and drug product in a phase-appropriate GxP environment
- Receives and records results in support of a variety of different groups including QC, MFG, Cell Culture PD, Purification PD and Formulation.
- The position may require occasional "off hours" and holiday support as required
- Responsible for operational aspects of the laboratory through ordering, equipment maintenance and organization.
- 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, ELISAs, HPLC, or PCR methods.
- Experience or understanding of GMP/GLP requirements.
- 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.
- Experienced in method development, qualification, and transfer.
- Knowledge of biopharmaceutical development is a plus.
- Experience working in a cross-functional environment.
- 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. This is a fully onsite role.
Bachelor’s/ Master’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 2- 4 years of experience in a Biologics or Pharmaceutical environment.
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.
In the U.S., the salary range for this position is $ 76,000 to $ 114,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.