Scientist 2, Separations and Biophysics Assays

DESCRIPTION

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of Bio Marin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

Bio Marin'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 Bio Marin'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.

The Analytical Sciences team within Technical Development Services at Bio Marin Pharmaceutical Inc. is seeking Scientist 2to support protein/enzyme replacement therapy, small molecule, peptide and oligo programs. Reporting to the Associate Director of Analytical Sciences, this person will be a member of Glycan Analysis and Biophysical Characterization team.

The successful candidate will lead the development, qualification, transfer, and lifecycle management of analytical methods, with a strong emphasis on glycan characterization and product quality attribute assessment. The role requires hands-on expertise in LC-MS, HILIC, CE, cIEF/icIEF, SEC, IEX, RP chromatography, and other orthogonal analytical techniques to support product characterization, control strategy development, comparability assessments, process and formulation development, and regulatory submissions.

The ideal candidate is a self-motivated, agile scientist with deep expertise in glycan analysis, a broad analytical background across multiple modalities, and the ability to rapidly learn new technologies. Strong communication, collaboration, and problem-solving skills are essential, as this individual will partner closely with cross-functional teams across Analytical Sciences, Process Development, Formulation Development, Quality, Regulatory Affairs, and Research in a fast-paced environment.

Experience supporting CMC development, regulatory submissions, and compliance with USP, ICH, and global regulatory expectations is highly desirable.

We are seeking a scientifically curious and collaborative analytical scientist who combines deep glycan characterization expertise with the versatility to address diverse analytical challenges across multiple therapeutic modalities.

• Lead analytical method development, qualification, transfer, remediation in support of process development and product characterization activities for clinical and commercial portfolio consisting of various modalities across different phases of CMC development.
• Support pre- and post-IND regulatory submission by authoring and reviewing analytical sections and responding to queries from regulatory agencies.
• Develop and optimize chromatography- , capillary- , spectroscopy- , and mass spectrometry-based analytical methods with a focus on Glycan Analysis.
• Prepare, review, and approve analytical and technical protocols and reports.
• Document experiments, data, and…