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.
Primary responsibility is support for the Assay Services subgroup within Analytical Sciences. This position involves performance of a variety of analytical assays with adherence to strict timelines. Assays may include enzyme activity, total protein, cell-based bioassays, chromatography and electrophoresis, done under the supervision of more senior personnel. Assists in the qualification of assay methods and in their transfer to the Quality Control laboratories. 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 person will also record and interpret data generated and properly record into the company Electronic Notebook and/or Labware LIMS.
Data generated is used for lot release and stability evaluation of clinical batches of drug substance and drug product. Data generated is also used in decisions involving process development/formulation projects.
- Performs analytical assays for samples within and outside the purview of assay services. Including plate-based bioassays, PCR, gel and capillary electrophoresis, and HPLC methods.
- Under appropriate supervision, assists Research Associates and Scientists in the qualification of assay methods for transfer to the Quality Control Analytical and In-Process laboratories.
- With increasing experience, 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, and PCR methods.
- Collaborative skills to work in a cross-functional environment.
- Excellent communication, collaboration and writing skills.
- Proven data analysis, interpretation and scientific communication skills.
- 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
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.
Four-year degree in a biological or physical science, with typical academic laboratory classes.
- 0-2 years’ industry experience in biological or chemical laboratory work.
- Knowledge and experience in lab processes and procedures. Experience with cell culture sterile technique is preferred.
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.