Research Associate, Process Analytics
Hiring Manager: Holly London ([email protected]), Jeannette Segarra ([email protected])
Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
- Primary responsibility: Execute product testing to support Drug Substance and Drug Product process development teams
- Perform non-routine testing of in-process samples, and final product samples of key projects for the TDS processing team
- Conduct analytical tests using techniques such as HPLC, UPLC, CE, FTIR, and plate-based methods
- Document all test results accurately and in compliance with Good Laboratory Practices (GLP) and company SOPs.
- Collaborate with cross-functional teams including Drug Substance Technologies, Drug Product Device Technologies, Manufacturing, and Quality.
- Provide concise and quantitative analysis of data and interpretation of experimental results.
- Provide effective oral presentations at departmental meetings
- Report progress to the manager on a weekly basis on each program
- Write up experimental plans and results and share with collaborators and supervisor; present data proactively and regularly in group meetings.
- Catalogue data/reports electronically in an accessible manner for inspections
- Strong understanding of GMP, GLP, and regulatory standards
- Familiar with protein chemistry/function and bioassays
- Experienced in cell culture techniques and protein expression/activity readout methods
- 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 in method troubleshooting, qualification, and transfer
- Knowledge of biopharmaceutical development is a plus
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.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.