Research Associate, AnalyticalLocation 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. The Analytical Chemistry department, a part of Process Sciences within Tech Ops, supports all assay needs in Tech Ops. Our scientists and associates are experts in analytics of small molecules, peptides, complex glycosylated enzymes, PEGylated proteins and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, we assess the capability of our processes by analyzing in-process samples all the way from bioreactors through purification steps to the drug substance and develop release assays for transfer to Quality. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients’ lives.
The Analytical Chemistry department at BioMarin Pharmaceutical Inc. is seeking a skilled Analytical Biochemist, Biologist, and/or Cellular Potency assay expert at the Research Associate level to join a team focused on supporting gene therapy & enzyme replacement therapy. The successful candidate will be a self-motivated, independent and critical thinker who has proven ability to work in a multi-disciplinary and fast-paced environment, and solid communication skills. The candidate will develop and execute a wide variety of analytical methods and assays for the characterization of therapeutic candidates in development with a particular focus on critical program needs including CMC development for INDs and BLAs. An ideal candidate will have experience in standard chromatographic and activity measurements and an interest in learning about biotechnology product development. A good scientific understanding of protein biophysical chemistry and activity assays is essential.
- Execution of relevant experiments to support development and qualification of analytical assays for biologics in development
- Methods typically include biochemical (size, charge, reverse-phase, etc), as well as binding, activity, and internalization assays.
- Plan and execute experimental studies in an efficient manner to meet project goals and timelines
- Provide concise and quantitative analysis of data and interpretation of experimental results.
- Provide effective oral presentations at departmental and interdepartmental meetings
- Contribute to IND and BLA sections collaboratively and as needed
- Report progress to the manager on a monthly basis on each program
- Write up methods, qualification reports, results & share with collaborators and supervisor; present data proactively and regularly in group meetings and CMC sub teams; communicate plans and results to collaborators and manager iteratively
- Catalogue data/reports electronically in an accessible manner for inspections
- Good understanding of protein chemistry, structure, and function
- Proven technical skills in running of biochemical, and/or bioassay methods for characterization of proteins
- 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
Bachelors degree in biological sciences and at least 2 years of relevant experience, or minimal experience with Masters.
Operation of standard laboratory equipment for biochemistry and for cellular assays
Will report to a Principal Scientist in Analytical Chemistry.
SUPERVISOR RESPONSIBILITYNo immediate supervisory role.
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.