BioMarin Pharmaceutical Inc.
Research Associate, Process Analytics
BioMarin Pharmaceutical Inc., Novato, California, United States, 94949
BioMarin Pharmaceutical Inc. is a global biotechnology company focused on translating genetic discoveries into new medicines that advance human health.
Summary
The Analytical Sciences department at BioMarin Pharmaceutical Inc. is seeking a skilled Analytical Biochemist and/or Biologist 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 experience of working in a multi-disciplinary and fast-paced environment, and solid communication skills. The candidate will execute a wide variety of analytical methods and assays for the characterization of therapeutic candidates in development with a particular focus on testing to support clinical and commercial process development teams.
Responsibilities
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 Experience
Required Skills
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 Desired Skills
Experience in method troubleshooting, qualification, and transfer Knowledge of biopharmaceutical development is a plus Education
Research Associate 1: Bachelors degree in biological sciences and 1-2 years of relevant experience. Equipment
Operation of standard laboratory equipment for biochemistry and for cellular assays Contacts
Will report to the Sr. Manager Analytical Services. Supervisor Responsibility
No immediate supervisory role. 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.
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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 Experience
Required Skills
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 Desired Skills
Experience in method troubleshooting, qualification, and transfer Knowledge of biopharmaceutical development is a plus Education
Research Associate 1: Bachelors degree in biological sciences and 1-2 years of relevant experience. Equipment
Operation of standard laboratory equipment for biochemistry and for cellular assays Contacts
Will report to the Sr. Manager Analytical Services. Supervisor Responsibility
No immediate supervisory role. 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.
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