Sr. Scientist I, Analytical Sciences

BioMarin Pharmaceutical Inc

  • Novato, CA
  • 1 day ago
  • $130,400–$179,300 Per Year

Highlights

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. 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.

Numbers & Facts

LocationNovato, CA
Salary$130,400–$179,300 Per Year

Description

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Novato

BioMarin Pharmaceutical

Sr. Scientist I, Analytical Sciences

Location: Novato, United States

Workstyle: Onsite Only

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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 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.

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 organisationâ€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

Support the organisationâ€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.

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The salary range for this position is: $130,400 to $179,300. 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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