Sr. Scientist I, Analytical Sciences

BioMarin Pharmaceutical Inc. • Novato, CA

32d • Onsite

About The Position

The Analytical Sciences team within Technical Development Services is seeking a Sr. Scientist I to support analytical development across BioMarin’s pipeline, primarily for synthetic molecules such as small molecules, peptides, and oligonucleotides. The role supports the development, qualification, transfer, and lifecycle management of analytical methods, using expertise in LC-MS, U/HPLC, and characterization techniques including NMR, DSC, XRPD, and dissolution testing. These methods support synthetic drug characterization, control strategy development, comparability assessments, process and formulation development, and regulatory submissions.

The scientist will work across analytical development activities, contribute to scientific and regulatory documentation, maintain laboratory instruments and records, and collaborate with cross-functional teams and external partners. The role also includes mentoring junior scientists and research associates as needed. This is a full-time onsite position in Novato, California, with minimal travel (0–5%); occasional travel may be required based on business needs.

Requirements

• PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry, or a related scientific discipline and at least 5 years of relevant post-graduate industry experience; OR a master's degree in one of these disciplines or a related scientific discipline and at least 10 years of relevant post-graduate industry experience.
• Strong expertise in analytical development for synthetic molecules and analytical control strategy development.
• Hands-on experience with separation science and mass spectrometry, including LC-MS.
• Experience with Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Reverse Phase Chromatography (RP), and Hydrophilic Interaction Liquid Chromatography (HILIC).
• Experience with common detection technologies including UV, CAD, ELSD, FLD, and MS.
• Ability to integrate data from multiple analytical platforms to solve complex characterization challenges.
• Experience developing and executing phase-appropriate analytical methods supporting Drug Substance (DS), Drug Product (DP), formulation development, process characterization, comparability studies, and control strategy development.
• Working knowledge of USP, ICH, FDA, EMA, PMDA, and other global regulatory requirements.
• Strong scientific writing, presentation, and communication skills.
• Excellent critical thinking and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced environment and rapidly learn new technologies.
• Ability to collaborate effectively with cross-functional teams.

Nice To Haves

• Experience supporting late-stage analytical development activities, including Phase III clinical development, Process Performance Qualification (PPQ), NDA filings, or commercial product support.
• Experience authoring, reviewing, or supporting regulatory submissions, including INDs, MAAs, and responses to health authority questions.
• Broader analytical development experience across additional molecular modalities.
• Demonstrated ability to quickly learn new technologies and contribute across diverse analytical disciplines.

Responsibilities

• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods for 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 instrument qualification, maintenance, and troubleshooting.
• Mentor junior scientists and research associates as needed.
• Collaborate with internal and external partners across Technical Development, Quality, Regulatory Affairs, and Research teams.
• Support environmental protection, injury prevention, and continual improvement of EHS management systems by identifying hazards, reporting incidents, and participating in EHS initiatives and training.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree