Scientist 1, AnalyticalLocation Novato, California
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 Analytical Chemistry department at BioMarin Pharmaceutical Inc. is seeking a skilled expert in Analytical Biochemistry, Biology, and/or Cellular Potency assays with CMC experience in biologics at the Scientist level to join a team focused on supporting gene therapy & protein therapeutics. 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 a wide variety of analytical methods and assays for the characterization of at least one therapeutic candidate in development with a particular focus on critical program needs including CMC development for INDs and BLAs. An ideal candidate will have experience in drug development, including experience as a participant on CMC teams. Experience with assessing the QC-readiness of assays is a plus. 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.
- Understand CMC needs, deliverables, timelines, responsible for delivery of results and proactively plan work and resources for timely execution
- Help write IND and BLA sections collaboratively and as needed
- Report progress to the manager on a monthly basis on each program
- Develop a relevant tool box of qualitative and quantitative assays for process development as well as product characterization, including release assays to follow critical quality attributes;
- 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
- Train colleagues and associates when needed
- Deep understanding of protein chemistry, structure, and function
- Proven technical skills in development of biochemical, and/or bioassay methods for characterization of biologic samples
- Experienced in method development, qualification, and transfer
- 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
- Experience working on CMC teams
- Understanding of ICH, USP, Ph Eur, FDA and relevant guidelines for CMC development; interest in developing CQAs
- Experienced manager of laboratory scientists and associates
- Ability to travel
Ph.D. in biological sciences, preferably biochemistry, biophysical characterization of proteins or virus (or relevant industry experience). Less than 5 years of relevant experience in academia or industry post Ph.D. will be considered for a Scientist position. At least 5 years for a Senior Scientist.
Operation of standard laboratory equipment for biochemistry and for cellular assaysWe 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.