Sr. Scientist , Analytical Sciences

Position: Sr. Scientist I, Analytical Sciences
Description Who We Are 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. Sr. Scientist I, Analytical Sciences Summary The  Analytical Sciences team within Technical Development Services is seeking a Sr.

Scientist I to support analytical development activities across Bio Marin's pipeline, with a primary focus on synthetic molecules, including small molecules, peptides, and oligonucleotides.

The successful candidate will support the development, qualification, transfer, and lifecycle management of analytical methods. The role requires expertise in LC-MS, U/HPLC, and a variety of analytical characterization techniques, including NMR, DSC, XRPD, and dissolution testing. These methods will support synthetic drug characterization, control strategy development, comparability assessments, process development, formulation development, and regulatory submissions.

The ideal candidate is a highly motivated and adaptable scientist with strong expertise in synthetic drug analytical development and control strategies. Success in this role requires excellent communication, collaboration, and problem-solving skills, as well as the ability to work effectively with cross-functional teams including Analytical Sciences, Process Development, Formulation Development, Quality, Regulatory Affairs, and Research.

Responsibilities Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods to support synthetic drug development, including small molecules, peptides, and oligonucleotides.

Support analytical characterization, comparability assessments, process development, formulation development, and control strategy implementation.

Prepare, review, and approve analytical protocols, technical reports, and scientific documentation.

Author and review analytical sections of regulatory submissions and support responses to regulatory agency questions.

Document experiments, data, and scientific findings in electronic laboratory systems in a manner suitable for regulatory inspection.

Participate in laboratory operations, including…