Research Associate 1, Process Analytics and Services (Analytical Sciences)

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n BioMarin Pharmaceuticaln

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Research Associate 1, Process Analytics and Services (Analytical Sciences)

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Location: Novato, United States

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Workstyle: Onsite Only

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Apply

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Who We Are

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BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

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Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

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Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best xe2x80x93 people with the right technical expertise and a relentless drive to solve real problems xe2x80x93 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, wexe2x80x99ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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About Technical Operations

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BioMarinxe2x80x99s 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 BioMarinxe2x80x99s 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

The Analytical Sciences department is seeking a Research Associate 1 to join the Process Analytics & Services (PAS) function. This is a hands-on laboratory role supporting analytical testing and characterization of therapeutic candidates across process development, early clinical, late-stage, and commercial programs.

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The selected candidate will execute a variety of GxP and non-GxP analytical methods to support drug substance and drug product process development, method lifecycle activities, and cross-functional technical investigations. This role requires strong laboratory execution, data analysis, and collaboration skills in a fast-paced, multi-disciplinary environment.

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KEY RESPONSIBILITIES

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Analytical Testing & Data Execution

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• Perform routine and non-routine analytical testing to support process development (Drug Substance and Drug Product) and lifecycle programs n
• Execute assays including: n

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• Chromatographic methods (e.g., HPLC/UPLC) n
• Capillary electrophoresis (CE) and gel-based electrophoresis (e.g., SDS-PAGE) n
• Spectrophotometric methods (e.g., UV/Vis, FTIR) n
• Plate-based assays (e.g., ELISA) and cell-based bioassays n
• Basic nucleic acid and compendial physicochemical testing n

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• Accurately document test results in accordance with GMP/GLP and internal procedures n
• Analyze and interpret analytical data and communicate results clearly n

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Method Lifecycle & Laboratory Support

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• Support method qualification, optimization, validation, and transfer activities under supervision n
• Assist with drafting and updating technical documents (e.g., analytical procedures, protocols, reports) n
• Support troubleshooting of analytical methods and laboratory workflows n
• Maintain laboratory equipment and ensure readiness of reagents, standards, and materials n

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Process Development & Cross-Functional Support

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• Provide analytical testing support for process development, manufacturing, and investigation activities n
• Collaborate with cross-functional teams including: n

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• Drug Substance Technologies (DST) n
• Formulation and Drug Product Technologies (FPT) n
• Manufacturing Sciences & Technology (MSAT) n
• Manufacturing, Quality Control, and Quality teams n

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• Support in-process, release, and stability-related analytical testing n

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Compliance & Inspection Readiness

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• Ensure all work is performed in accordance with GxP requirements and BioMarin procedures n
• Maintain laboratory documentation and data in an inspection-ready state n
• Support regulatory inspections, audits, and site readiness activities n

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Data Management & Communication

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• Document experimental plans, results, and conclusions clearly and accurately n
• Maintain organized electronic records to ensure traceability and data integrity n
• Present data and progress updates in team meetings n

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Continuous Improvement & Team Support

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• Contribute to improvement of laboratory processes, workflows, and documentation practices n
• Support training and knowledge sharing within the team as appropriate n

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REQUIRED SKILLS

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• Hands-on experience with one or more analytical techniques (e.g., HPLC/UPLC, CE, ELISA, spectrophotometry) n
• Basic understanding of GMP/GLP principles and data integrity expectations n
• Ability to analyze and interpret data n
• Strong written and oral communication skills n
• Strong organizational skills with the ability to manage multiple tasks n
• Ability to work independently and collaboratively in a team environment n

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PREFERRED SKILLS

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• Hands-on experience with chromatographic (LC/HPLC/UPLC) and capillary electrophoresis (CE) methods n
• Exposure to biopharmaceutical development or protein characterization n
• Experience with bioassays or cell-based assays n
• Familiarity with analytical method lifecycle activities (e.g., qualification, troubleshooting, validation, or transfer) n
• Experience working in a cross-functional or fast-paced environment n

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EDUCATION & EXPERIENCE

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• Bachelorxe2x80x99s degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field n
• 1xe2x80x932 years of relevant experience in a pharmaceutical or biotechnology environment n
• Masterxe2x80x99s degree is a plus but not required n

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ADDITIONAL INFORMATION

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• This is a fully onsite laboratory role n
• Routine work includes handling chemicals and biological materials with appropriate safety practices n
• May require occasional flexibility to support operational needs n

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EQUIPMENT

Operation of standard laboratory equipment for biochemistry and for cellular assays

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REPORTING STRUCTURE

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• Reports to: Sr. Manager, Process Analytics & Services n
• No supervisory responsibilities n

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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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.xc2xa0

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The salary range for this position is: $72,000 to $99,000. 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

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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.

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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.

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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.

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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

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Equal Opportunity Employer/Veterans/Disabled

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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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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, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis 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.

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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 xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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