Sr. Scientist I, Analytical Sciences

BioMarin Pharmaceutical•Novato, CA

3d•Onsite

About The Position

BioMarin’s Analytical Sciences team within Technical Development Services is seeking a Sr. Scientist I to support analytical development across its pipeline, primarily for synthetic molecules such as small molecules, peptides, and oligonucleotides. The scientist will support analytical method development, qualification, transfer, and lifecycle management. Methods and characterization work will support synthetic drug characterization, control strategy development, comparability assessments, process and formulation development, and regulatory submissions. The position involves developing and optimizing analytical methods using chromatography, capillary techniques, spectroscopy, and mass spectrometry, and applying LC-MS, U/HPLC, and other characterization approaches. The scientist prepares and reviews scientific documentation, contributes to regulatory submissions and agency responses, maintains inspection-ready electronic laboratory records, and participates in laboratory operations. The role also includes mentoring junior colleagues as needed and collaborating with internal and external cross-functional partners. This is a full-time onsite position in Novato, California, with minimal travel required (0–5%); occasional travel may be necessary based on business needs. The position reports to a Sr. Scientist II within Analytical Sciences.

Requirements

PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry, or a related scientific discipline, with 5 or more years of relevant post-graduate industry experience; or a master’s degree in one of these fields or a related scientific discipline, with 10 or more 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, drug product, 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.
Excellent collaboration skills and ability to work 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, and 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 the organization’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
Contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents, and participating in EHS initiatives and training.