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n Novaton
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n BioMarin Pharmaceuticaln
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Research Associate 1, Analytical Services
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Location: Novato, United States
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Workstyle: Onsite Only
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Apply
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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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Research Associate, Analytical Services
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JOB DESCRIPTION
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Research Associate is an onsite laboratory position. The selected candidate will work in the Analytical Services team, under the Analytical Sciences group to assist in the advancement of BioMarinxe2x80x99s therapeutics for clinical evaluation and potential commercialization. The selected candidate will be responsible for applying technical expertise to the execution of laboratory activities related to GxP and non-GxP testing of early clinical programs and their transition to late stage, commercial and post-commercialization.
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Under limited supervision, the candidate will ensure phase-appropriate performance, troubleshooting, optimization, qualification, validation, and transfer of methods for testing pharmaceutical drug substance and drug product. In addition, this role will support training for site QC / Global QC / Contract Test Labs / In-Country Testing Laboratories personnel in new techniques and methods.xc2xa0 The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.xc2xa0
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RESPONSIBILITIES
Responsibilities include, but are not limited to the following:
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Method Qualification, Validation, Transfer and Optimization
xe2x80xa2xc2xa0xc2xa0xc2xa0 Lead and/or perform analytical testing such as HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports
xe2x80xa2xc2xa0xc2xa0xc2xa0 Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarinxe2x80x99s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners
xe2x80xa2xc2xa0xc2xa0xc2xa0 Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay
xe2x80xa2xc2xa0xc2xa0xc2xa0 Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams
xe2x80xa2xc2xa0xc2xa0xc2xa0 Support the maintenance of method and analytical equipment performance
xe2x80xa2xc2xa0xc2xa0xc2xa0 Trend, analyze and interpret analytical results.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Conduct data review and sign-off in applicable document and data management systems
xe2x80xa2xc2xa0xc2xa0xc2xa0 Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process
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Regulatory Compliance, Audit and Site Support
xe2x80xa2xc2xa0xc2xa0xc2xa0 Lead/support the effort to maintain the laboratory in an inspection-ready state including support of equipment management (e.g., check reference materials for expiration, etc.)
xe2x80xa2xc2xa0xc2xa0xc2xa0 Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
xe2x80xa2xc2xa0xc2xa0xc2xa0 General understand and application of USP, EP, JP and ICH regulatory guidelines and directives
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Cross-Functional Support
xe2x80xa2xc2xa0xc2xa0xc2xa0 Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations
xe2x80xa2xc2xa0xc2xa0xc2xa0 Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing
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Process Improvement and Training
xe2x80xa2xc2xa0xc2xa0xc2xa0 Act as technical resource (SME) to train other Analysts in areas of expertise
xe2x80xa2xc2xa0xc2xa0xc2xa0 Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.
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Required Skills:
xe2x80xa2xc2xa0xc2xa0xc2xa0 Experience in performing one or more combinations of analytical methods including HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays Experience or understanding of GMP/GLP requirements.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Ability to analyze and interpret data.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Good written and oral communication skills, with the ability to communicate complex information.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Strong organizational skills with the ability to effectively multi-task and prioritize.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.
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Desired Skills:
xe2x80xa2xc2xa0xc2xa0xc2xa0 Experienced in method development, qualification, and transfer.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Knowledge of biopharmaceutical development is a plus.
xe2x80xa2xc2xa0xc2xa0xc2xa0 Experience working in a cross-functional environment.
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Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities.xc2xa0 The employee will be trained to use common laboratory equipment and minimize exposure to hazards.xc2xa0xc2xa0 Desktop or laptop computer work is also a major component of the job. This is a fully onsite role.xc2xa0 The position may require occasional non-routine work hours support.
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Education
xe2x80xa2xc2xa0xc2xa0xc2xa0 Bachelorxe2x80x99s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.
xe2x80xa2xc2xa0xc2xa0xc2xa0 A Masterxe2x80x99s Degree in a related field is desirable, but not required.
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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.
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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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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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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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