Scientist 2, Separations and Biophysics Assays

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Novato

BioMarin Pharmaceutical

Scientist 2, Separations and Biophysics Assays

Location: Novato, United States

Workstyle: Onsite Only

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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 peopleâ€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

BioMarinâ€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 BioMarinâ€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.

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SUMMARY

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The Analytical Sciences team within Technical Development Services at BioMarin Pharmaceutical Inc. is seeking Scientist 2Â 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.

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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.

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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.

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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.

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RESPONSIBILITIES

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• 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.

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EXPERIENCE

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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.

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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.

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EDUCATION

Scientist 2:

PhD degree in Chemistry, Biochemistry, pharmaceutical chemistry or related field with 4+Â years of relevant post-graduate experience.

(OR)

Masterâ€s degree in chemistry, Biochemistry, pharmaceutical chemistry or related field with 8+ years of relevant post-graduate experience.

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Sr. Scientist 1:

PhD degree in Chemistry, Biochemistry, pharmaceutical chemistry or related field with 6+ years of relevant post-graduate experience.Â

(OR)

Masterâ€s degree in chemistry, Biochemistry, pharmaceutical chemistry or related field with 10+ years of relevant post-graduate experience.

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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 RegulatoryÂ

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ONSITE, REMOTE, OR FLEXIBLEÂ

Full-time onsite Mon-Friday in Novato, CA

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TRAVEL REQUIREDÂ

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.

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The salary range for this position is: $118,400 to $162,800. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.

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