DescriptionSr. Scientist I, Analytical SciencesSummaryThe Analytical Sciences team within Technical Development Services is seeking a
Sr. Scientist I to support analytical development activities across BioMarin'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 instrument qualification, maintenance, and troubleshooting activities.
- Mentor junior scientists and research associates as needed.
- Collaborate with internal and external partners across Technical Development, Quality, Regulatory Affairs, and Research teams.
Required QualificationsTechnical 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, including:
- Size Exclusion Chromatography (SEC)
- Ion Exchange Chromatography (IEX)
- Reverse Phase Chromatography (RP)
- Hydrophilic Interaction Liquid Chromatography (HILIC)
- Experience with common detection technologies, including:
- 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
- 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.
Preferred Qualifications- Experience supporting late-stage analytical development activities, including:
- Phase III clinical development
- Process Performance Qualification (PPQ)
- NDA filings
- Commercial product support
- Experience authoring, reviewing, or supporting regulatory submissions, including:
- 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.
Education & ExperienceSr. Scientist I- PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry, or a related scientific discipline with 5+ years of relevant post-graduate industry experience.
OR- Master's degree in Chemistry, Biochemistry, Pharmaceutical Chemistry, or a related scientific discipline with 10+ years of relevant post-graduate industry experience.
Reporting Structure- 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.
Location- Full-time onsite position in Novato, California.
Travel- Minimal travel required (0-5%).
- Occasional travel may be necessary based on business needs.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
