Sr. Scientist I, Analytical Sciences

About the role

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions, with a portfolio of therapies for achondroplasia, PKU, CLN2, MPS, Fabry disease, and Pompe disease. The Technical Operations group creates drugs for clinical trials and scales production for commercial markets, encompassing manufacturing, quality assurance, quality control, and global supply chain. The Analytical Sciences team within Technical Development Services seeks a Sr. Scientist I to support analytical development across BioMarin's pipeline, with primary focus on synthetic molecules including small molecules, peptides, and oligonucleotides. The role involves development, qualification, transfer, and lifecycle management of analytical methods using LC‑MS, U/HPLC, NMR, DSC, XRPD, and dissolution testing to support drug characterization, control strategy, comparability, process and formulation development, and regulatory submissions.

Responsibilities

• Develop and optimize chromatography‑, capillary‑, spectroscopy‑, and mass spectrometry‑based analytical methods for synthetic drug development (small molecules, peptides, 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 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.

Required Qualifications

Technical Skills

• 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 chromatographic techniques: Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Reverse Phase Chromatography (RP), Hydrophilic Interaction Liquid Chromatography (HILIC).
• Experience with detection technologies: UV, CAD, ELSD, FLD, 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.
• Proven ability to manage multiple priorities in a fast‑paced environment and rapidly learn new technologies.

Education & Experience

• PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry, or related scientific discipline with 5+ years of relevant post‑graduate industry experience.
• OR Master’s degree in Chemistry, Biochemistry, Pharmaceutical Chemistry, or related scientific discipline with 10+ years of relevant post‑graduate industry experience.

Preferred Qualifications

• Experience supporting late‑stage analytical development activities: Phase III clinical development, Process Performance Qualification (PPQ), NDA filings, commercial product support.
• Experience authoring, reviewing, or supporting regulatory submissions (INDs, MAAs, 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.

Additional Details

Reports to a Sr. Scientist II within Analytical Sciences; collaborates with leaders and stakeholders across Research & Early Development, Technical Development, Quality, Regulatory Affairs, and external partners. Full‑time onsite position in Novato, California with daily onsite presence required. Minimal travel (0‑5%); occasional travel may be necessary based on business needs.