About this role
Sr. Scientist I, Analytical Sciences
Location
- Novato, California
Category: Research
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Description
Who We Are
BioMarin 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 BioMarin 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
BioMarin’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 BioMarin’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 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 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, including:
- Size Exclusion Chromatography (SEC)
- Ion Exchange Chromatography (IEX)
- Reverse Phase Chromatography (RP)
- Hydrophilic Interaction Liquid Chromatography (HILIC)
- Experience with common detection technologies, including:
- 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
- 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 & Experience
Sr. 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.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
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