Clinical Research Associate Jobs in Rohnert Park, CA

Description
DESCRIPTION
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.
SUMMARY
The Analytical Sciences team within Technical Development Services at BioMarin Pharmaceutical Inc. is seeking Scientist 2 to support protein/enzyme replacement therapy, small molecule, peptide and oligo programs. Reporting to the Associate Director of Analytical Sciences, this person will be a member of Glycan Analysis and Biophysical Characterization team.
The successful candidate will lead the development, qualification, transfer, and lifecycle management of analytical methods, with a strong emphasis on glycan characterization and product quality attribute assessment. The role requires hands-on expertise in LC-MS, HILIC, CE, cIEF/icIEF, SEC, IEX, RP chromatography, and other orthogonal analytical techniques to support product characterization, control strategy development, comparability assessments, process and formulation development, and regulatory submissions.
The ideal candidate is a self-motivated, agile scientist with deep expertise in glycan analysis, a broad analytical background across multiple modalities, and the ability to rapidly learn new technologies. Strong communication, collaboration, and problem-solving skills are essential, as this individual will partner closely with cross-functional teams across Analytical Sciences, Process Development, Formulation Development, Quality, Regulatory Affairs, and Research in a fast-paced environment. Experience supporting CMC development, regulatory submissions, and compliance with USP, ICH, and global regulatory expectations is highly desirable.
We are seeking a scientifically curious and collaborative analytical scientist who combines deep glycan characterization expertise with the versatility to address diverse analytical challenges across multiple therapeutic modalities.
RESPONSIBILITIES

• Lead analytical method development, qualification, transfer, remediation in support of process development and product characterization activities for clinical and commercial portfolio consisting of various modalities across different phases of CMC development.
• Support pre- and post-IND regulatory submission by authoring and reviewing analytical sections and responding to queries from regulatory agencies.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods with a focus on Glycan Analysis.
• Prepare, review, and approve analytical and technical protocols and reports.
• Document experiments, data, and findings electronically in an accessible manner for inspections.
• Participate in the general lab and instrument maintenance.
• Mentor junior scientist(s) and research associate(s) in the team as needed.

EXPERIENCE
Required Skills:

• Strong expertise in glycan characterization and analysis, including method development, qualification, troubleshooting, and data interpretation using LC-MS, CE-based methods, cIEF, HILIC-FLD/MS, and other orthogonal analytical techniques relevant to biologics and complex modalities.
• Hands-on experience with separation science and mass spectrometry, including LC-MS and chromatographic techniques such as SEC, IEX, RP, and HILIC, along with common detection platforms (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 to support drug substance (DS), drug product (DP), formulation development, process characterization, comparability, and control strategy activities across clinical and commercial stages.
• Broad analytical development experience with biologics and an interest in applying scientific knowledge across multiple molecular modalities and platforms.
• Working knowledge of USP, ICH, and global regulatory expectations from health authorities including FDA, EMA, PMDA, and other international agencies.
• Excellent scientific communication skills with demonstrated ability to effectively present data, write technical reports, influence cross-functional teams, and communicate complex scientific concepts to diverse audiences.
• Strong problem-solving and critical-thinking skills with the ability to independently drive investigations and make technically sound, data-driven decisions.
• Demonstrated ability to thrive in a fast-paced, dynamic environment, manage multiple priorities simultaneously, and rapidly learn and apply new analytical technologies and scientific concepts.

Desired Skills:

• Experience with advanced characterization techniques such as CE-SDS, icIEF/cIEF, intact mass analysis, peptide mapping, glycan profiling, and other mass spectrometry-based workflows.
• Familiarity with small molecules and conjugated molecules, analytical techniques and characterization approaches is a plus.
• Experience authoring, reviewing, or supporting regulatory submissions, including INDs, BLAs, MAAs, and responses to health authority questions.
• Demonstrated ability to quickly learn new technologies, expand technical expertise beyond a primary specialty area, and contribute across a broad range of analytical activities.

EDUCATION
Scientist 2:
PhD degree in Chemistry, Biochemistry, pharmaceutical chemistry or related field with 4+ years of relevant post-graduate experience.
(OR)
Master's degree in chemistry, Biochemistry, pharmaceutical chemistry or related field with 8+ years of relevant post-graduate experience.
Sr. Scientist 1:
PhD degree in Chemistry, Biochemistry, pharmaceutical chemistry or related field with 6+ years of relevant post-graduate experience.
(OR)
Master's degree in chemistry, Biochemistry, pharmaceutical chemistry or related field with 10+ years of relevant post-graduate experience.
CONTACTS
Will report to Associate Director of Analytical Sciences and interface with internal department leaders and external partners from Research and Early Development, Technical Development, Quality, and Regulatory
ONSITE, REMOTE, OR FLEXIBLE
Full-time onsite Mon-Friday in Novato, CA
TRAVEL REQUIRED
None to minimal (0-5%). Occasional travel is only 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.