Description

DESCRIPTION

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.