Careers Home Our Story Working Here Career Areas Locations { "@context": "http://schema.org", "@type": "JobPosting", "datePosted": "2026-06-15", "description": "
About Technical Operations
BioMarin\u2019s 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 BioMarin\u2019s 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.
Research Associate, Analytical Services\u00A0\u00A0JOB DESCRIPTION\u00A0Research 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 BioMarin\u2019s 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.\u00A0Under 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.\u00A0 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.\u00A0 \u00A0RESPONSIBILITIESResponsibilities include, but are not limited to the following:\u00A0Method Qualification, Validation, Transfer and Optimization\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports\u2022\u00A0\u00A0\u00A0 Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin\u2019s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners\u2022\u00A0\u00A0\u00A0 Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay\u2022\u00A0\u00A0\u00A0 Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams\u2022\u00A0\u00A0\u00A0 Support the maintenance of method and analytical equipment performance\u2022\u00A0\u00A0\u00A0 Trend, analyze and interpret analytical results.\u2022\u00A0\u00A0\u00A0 Conduct data review and sign-off in applicable document and data management systems\u2022\u00A0\u00A0\u00A0 Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process\u00A0Regulatory Compliance, Audit and Site Support\u2022\u00A0\u00A0\u00A0 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.)\u2022\u00A0\u00A0\u00A0 Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)\u2022\u00A0\u00A0\u00A0 General understand and application of USP, EP, JP and ICH regulatory guidelines and directives\u00A0Cross-Functional Support\u2022\u00A0\u00A0\u00A0 Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations\u2022\u00A0\u00A0\u00A0 Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing\u00A0Process Improvement and Training\u2022\u00A0\u00A0\u00A0 Act as technical resource (SME) to train other Analysts in areas of expertise\u2022\u00A0\u00A0\u00A0 Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.\u00A0Required Skills:\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Ability to analyze and interpret data.\u2022\u00A0\u00A0\u00A0 Good written and oral communication skills, with the ability to communicate complex information.\u2022\u00A0\u00A0\u00A0 Strong organizational skills with the ability to effectively multi-task and prioritize.\u2022\u00A0\u00A0\u00A0 Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.\u00A0Desired Skills:\u2022\u00A0\u00A0\u00A0 Experienced in method development, qualification, and transfer.\u2022\u00A0\u00A0\u00A0 Knowledge of biopharmaceutical development is a plus.\u2022\u00A0\u00A0\u00A0 Experience working in a cross-functional environment.\u00A0Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities.\u00A0 The employee will be trained to use common laboratory equipment and minimize exposure to hazards.\u00A0\u00A0 Desktop or laptop computer work is also a major component of the job. This is a fully onsite role.\u00A0 The position may require occasional non-routine work hours support.\u00A0Education\u2022\u00A0\u00A0\u00A0 Bachelor\u2019s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.\u2022\u00A0\u00A0\u00A0 A Master\u2019s Degree in a related field is desirable, but not required.
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.
\u00A0
Who We Are
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.
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.
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 \u2013 people with the right technical expertise and a relentless drive to solve real problems \u2013 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we\u2019ve 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.
", "hiringOrganization": "BioMarin Pharmaceutical Inc.", "employmentType": "Fulltime-Regular", "industry": "Quality", "identifier": "o6ulAfwf", "jobLocation": [ { "@type": "Place", "address": { "@type": "PostalAddress", "addressLocality": "Novato", "addressRegion": "California", "addressCountry": "United States" } } ], "title": "Research Associate 1, Analytical Services", "baseSalary": { "@type": "MonetaryAmount", "currency": "", "value": { "@type": "QuantitativeValue", "minValue": "", "maxValue": "", "unitText": "" } } } Research Associate 1, Analytical Services Location: Novato, California Category: Quality Apply Description About Technical Operations BioMarin’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 BioMarin’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. Research Associate, Analytical Services JOB DESCRIPTION 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 BioMarin’s 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. 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. 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. RESPONSIBILITIESResponsibilities include, but are not limited to the following: Method Qualification, Validation, Transfer and Optimization• 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.• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams• Support the maintenance of method and analytical equipment performance• Trend, analyze and interpret analytical results.• Conduct data review and sign-off in applicable document and data management systems• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process Regulatory Compliance, Audit and Site Support• 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.)• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives Cross-Functional Support• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing Process Improvement and Training• Act as technical resource (SME) to train other Analysts in areas of expertise• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance. Required Skills:• 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.• Ability to analyze and interpret data.• Good written and oral communication skills, with the ability to communicate complex information.• Strong organizational skills with the ability to effectively multi-task and prioritize.• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment. Desired Skills:• Experienced in method development, qualification, and transfer.• Knowledge of biopharmaceutical development is a plus.• Experience working in a cross-functional environment. Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support. Education• Bachelor’s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.• A Master’s Degree in a related field is desirable, but not required.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. Who We Are 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.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.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 – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve 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. Apply Apply Later ← Back to Current Openings Share lang: en_US Share LinkedIn Facebook Twitter Email Connect LinkedIn Glassdoor Biomarin.com sitemap privacy statement terms of use contact us glossary © 2018 Biomarin. All rights reserved. Powered by Jobvite
Careers Home Our Story Working Here Career Areas Locations { "@context": "http://schema.org", "@type": "JobPosting", "datePosted": "2026-06-15", "description": "
About Technical Operations
BioMarin\u2019s 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 BioMarin\u2019s 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.
Research Associate, Analytical Services\u00A0\u00A0JOB DESCRIPTION\u00A0Research 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 BioMarin\u2019s 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.\u00A0Under 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.\u00A0 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.\u00A0 \u00A0RESPONSIBILITIESResponsibilities include, but are not limited to the following:\u00A0Method Qualification, Validation, Transfer and Optimization\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports\u2022\u00A0\u00A0\u00A0 Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin\u2019s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners\u2022\u00A0\u00A0\u00A0 Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay\u2022\u00A0\u00A0\u00A0 Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams\u2022\u00A0\u00A0\u00A0 Support the maintenance of method and analytical equipment performance\u2022\u00A0\u00A0\u00A0 Trend, analyze and interpret analytical results.\u2022\u00A0\u00A0\u00A0 Conduct data review and sign-off in applicable document and data management systems\u2022\u00A0\u00A0\u00A0 Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process\u00A0Regulatory Compliance, Audit and Site Support\u2022\u00A0\u00A0\u00A0 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.)\u2022\u00A0\u00A0\u00A0 Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)\u2022\u00A0\u00A0\u00A0 General understand and application of USP, EP, JP and ICH regulatory guidelines and directives\u00A0Cross-Functional Support\u2022\u00A0\u00A0\u00A0 Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations\u2022\u00A0\u00A0\u00A0 Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing\u00A0Process Improvement and Training\u2022\u00A0\u00A0\u00A0 Act as technical resource (SME) to train other Analysts in areas of expertise\u2022\u00A0\u00A0\u00A0 Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.\u00A0Required Skills:\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Ability to analyze and interpret data.\u2022\u00A0\u00A0\u00A0 Good written and oral communication skills, with the ability to communicate complex information.\u2022\u00A0\u00A0\u00A0 Strong organizational skills with the ability to effectively multi-task and prioritize.\u2022\u00A0\u00A0\u00A0 Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.\u00A0Desired Skills:\u2022\u00A0\u00A0\u00A0 Experienced in method development, qualification, and transfer.\u2022\u00A0\u00A0\u00A0 Knowledge of biopharmaceutical development is a plus.\u2022\u00A0\u00A0\u00A0 Experience working in a cross-functional environment.\u00A0Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities.\u00A0 The employee will be trained to use common laboratory equipment and minimize exposure to hazards.\u00A0\u00A0 Desktop or laptop computer work is also a major component of the job. This is a fully onsite role.\u00A0 The position may require occasional non-routine work hours support.\u00A0Education\u2022\u00A0\u00A0\u00A0 Bachelor\u2019s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.\u2022\u00A0\u00A0\u00A0 A Master\u2019s Degree in a related field is desirable, but not required.
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.
\u00A0
Who We Are
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.
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.
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 \u2013 people with the right technical expertise and a relentless drive to solve real problems \u2013 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we\u2019ve 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.
", "hiringOrganization": "BioMarin Pharmaceutical Inc.", "employmentType": "Fulltime-Regular", "industry": "Quality", "identifier": "o6ulAfwf", "jobLocation": [ { "@type": "Place", "address": { "@type": "PostalAddress", "addressLocality": "Novato", "addressRegion": "California", "addressCountry": "United States" } } ], "title": "Research Associate 1, Analytical Services", "baseSalary": { "@type": "MonetaryAmount", "currency": "", "value": { "@type": "QuantitativeValue", "minValue": "", "maxValue": "", "unitText": "" } } } Research Associate 1, Analytical Services Location: Novato, California Category: Quality Apply Description About Technical Operations BioMarin’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 BioMarin’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. Research Associate, Analytical Services JOB DESCRIPTION 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 BioMarin’s 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. 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. 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. RESPONSIBILITIESResponsibilities include, but are not limited to the following: Method Qualification, Validation, Transfer and Optimization• 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.• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams• Support the maintenance of method and analytical equipment performance• Trend, analyze and interpret analytical results.• Conduct data review and sign-off in applicable document and data management systems• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process Regulatory Compliance, Audit and Site Support• 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.)• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives Cross-Functional Support• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing Process Improvement and Training• Act as technical resource (SME) to train other Analysts in areas of expertise• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance. Required Skills:• 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.• Ability to analyze and interpret data.• Good written and oral communication skills, with the ability to communicate complex information.• Strong organizational skills with the ability to effectively multi-task and prioritize.• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment. Desired Skills:• Experienced in method development, qualification, and transfer.• Knowledge of biopharmaceutical development is a plus.• Experience working in a cross-functional environment. Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support. Education• Bachelor’s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.• A Master’s Degree in a related field is desirable, but not required.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. Who We Are 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.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.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 – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve 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. Apply Apply Later ← Back to Current Openings Share lang: en_US Share LinkedIn Facebook Twitter Email Connect LinkedIn Glassdoor Biomarin.com sitemap privacy statement terms of use contact us glossary © 2018 Biomarin. All rights reserved. Powered by Jobvite
Careers Home Our Story Working Here Career Areas Locations { "@context": "http://schema.org", "@type": "JobPosting", "datePosted": "2026-06-15", "description": "
About Technical Operations
BioMarin\u2019s 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 BioMarin\u2019s 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.
Research Associate, Analytical Services\u00A0\u00A0JOB DESCRIPTION\u00A0Research 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 BioMarin\u2019s 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.\u00A0Under 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.\u00A0 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.\u00A0 \u00A0RESPONSIBILITIESResponsibilities include, but are not limited to the following:\u00A0Method Qualification, Validation, Transfer and Optimization\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports\u2022\u00A0\u00A0\u00A0 Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin\u2019s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners\u2022\u00A0\u00A0\u00A0 Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay\u2022\u00A0\u00A0\u00A0 Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams\u2022\u00A0\u00A0\u00A0 Support the maintenance of method and analytical equipment performance\u2022\u00A0\u00A0\u00A0 Trend, analyze and interpret analytical results.\u2022\u00A0\u00A0\u00A0 Conduct data review and sign-off in applicable document and data management systems\u2022\u00A0\u00A0\u00A0 Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process\u00A0Regulatory Compliance, Audit and Site Support\u2022\u00A0\u00A0\u00A0 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.)\u2022\u00A0\u00A0\u00A0 Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)\u2022\u00A0\u00A0\u00A0 General understand and application of USP, EP, JP and ICH regulatory guidelines and directives\u00A0Cross-Functional Support\u2022\u00A0\u00A0\u00A0 Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations\u2022\u00A0\u00A0\u00A0 Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing\u00A0Process Improvement and Training\u2022\u00A0\u00A0\u00A0 Act as technical resource (SME) to train other Analysts in areas of expertise\u2022\u00A0\u00A0\u00A0 Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.\u00A0Required Skills:\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Ability to analyze and interpret data.\u2022\u00A0\u00A0\u00A0 Good written and oral communication skills, with the ability to communicate complex information.\u2022\u00A0\u00A0\u00A0 Strong organizational skills with the ability to effectively multi-task and prioritize.\u2022\u00A0\u00A0\u00A0 Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.\u00A0Desired Skills:\u2022\u00A0\u00A0\u00A0 Experienced in method development, qualification, and transfer.\u2022\u00A0\u00A0\u00A0 Knowledge of biopharmaceutical development is a plus.\u2022\u00A0\u00A0\u00A0 Experience working in a cross-functional environment.\u00A0Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities.\u00A0 The employee will be trained to use common laboratory equipment and minimize exposure to hazards.\u00A0\u00A0 Desktop or laptop computer work is also a major component of the job. This is a fully onsite role.\u00A0 The position may require occasional non-routine work hours support.\u00A0Education\u2022\u00A0\u00A0\u00A0 Bachelor\u2019s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.\u2022\u00A0\u00A0\u00A0 A Master\u2019s Degree in a related field is desirable, but not required.
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.
\u00A0
Who We Are
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.
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.
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 \u2013 people with the right technical expertise and a relentless drive to solve real problems \u2013 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we\u2019ve 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.
", "hiringOrganization": "BioMarin Pharmaceutical Inc.", "employmentType": "Fulltime-Regular", "industry": "Quality", "identifier": "o6ulAfwf", "jobLocation": [ { "@type": "Place", "address": { "@type": "PostalAddress", "addressLocality": "Novato", "addressRegion": "California", "addressCountry": "United States" } } ], "title": "Research Associate 1, Analytical Services", "baseSalary": { "@type": "MonetaryAmount", "currency": "", "value": { "@type": "QuantitativeValue", "minValue": "", "maxValue": "", "unitText": "" } } } Research Associate 1, Analytical Services Location: Novato, California Category: Quality Apply Description About Technical Operations BioMarin’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 BioMarin’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. Research Associate, Analytical Services JOB DESCRIPTION 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 BioMarin’s 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. 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. 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. RESPONSIBILITIESResponsibilities include, but are not limited to the following: Method Qualification, Validation, Transfer and Optimization• 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.• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams• Support the maintenance of method and analytical equipment performance• Trend, analyze and interpret analytical results.• Conduct data review and sign-off in applicable document and data management systems• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process Regulatory Compliance, Audit and Site Support• 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.)• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives Cross-Functional Support• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing Process Improvement and Training• Act as technical resource (SME) to train other Analysts in areas of expertise• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance. Required Skills:• 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.• Ability to analyze and interpret data.• Good written and oral communication skills, with the ability to communicate complex information.• Strong organizational skills with the ability to effectively multi-task and prioritize.• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment. Desired Skills:• Experienced in method development, qualification, and transfer.• Knowledge of biopharmaceutical development is a plus.• Experience working in a cross-functional environment. Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support. Education• Bachelor’s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.• A Master’s Degree in a related field is desirable, but not required.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. Who We Are 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.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.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 – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve 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. Apply Apply Later ← Back to Current Openings Share lang: en_US Share LinkedIn Facebook Twitter Email Connect LinkedIn Glassdoor Biomarin.com sitemap privacy statement terms of use contact us glossary © 2018 Biomarin. All rights reserved. Powered by Jobvite
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{ "@context": "http://schema.org", "@type": "JobPosting", "datePosted": "2026-06-15", "description": "
About Technical Operations
BioMarin\u2019s 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 BioMarin\u2019s 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.
Research Associate, Analytical Services\u00A0\u00A0JOB DESCRIPTION\u00A0Research 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 BioMarin\u2019s 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.\u00A0Under 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.\u00A0 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.\u00A0 \u00A0RESPONSIBILITIESResponsibilities include, but are not limited to the following:\u00A0Method Qualification, Validation, Transfer and Optimization\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports\u2022\u00A0\u00A0\u00A0 Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin\u2019s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners\u2022\u00A0\u00A0\u00A0 Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay\u2022\u00A0\u00A0\u00A0 Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams\u2022\u00A0\u00A0\u00A0 Support the maintenance of method and analytical equipment performance\u2022\u00A0\u00A0\u00A0 Trend, analyze and interpret analytical results.\u2022\u00A0\u00A0\u00A0 Conduct data review and sign-off in applicable document and data management systems\u2022\u00A0\u00A0\u00A0 Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process\u00A0Regulatory Compliance, Audit and Site Support\u2022\u00A0\u00A0\u00A0 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.)\u2022\u00A0\u00A0\u00A0 Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)\u2022\u00A0\u00A0\u00A0 General understand and application of USP, EP, JP and ICH regulatory guidelines and directives\u00A0Cross-Functional Support\u2022\u00A0\u00A0\u00A0 Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations\u2022\u00A0\u00A0\u00A0 Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing\u00A0Process Improvement and Training\u2022\u00A0\u00A0\u00A0 Act as technical resource (SME) to train other Analysts in areas of expertise\u2022\u00A0\u00A0\u00A0 Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.\u00A0Required Skills:\u2022\u00A0\u00A0\u00A0 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.\u2022\u00A0\u00A0\u00A0 Ability to analyze and interpret data.\u2022\u00A0\u00A0\u00A0 Good written and oral communication skills, with the ability to communicate complex information.\u2022\u00A0\u00A0\u00A0 Strong organizational skills with the ability to effectively multi-task and prioritize.\u2022\u00A0\u00A0\u00A0 Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.\u00A0Desired Skills:\u2022\u00A0\u00A0\u00A0 Experienced in method development, qualification, and transfer.\u2022\u00A0\u00A0\u00A0 Knowledge of biopharmaceutical development is a plus.\u2022\u00A0\u00A0\u00A0 Experience working in a cross-functional environment.\u00A0Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities.\u00A0 The employee will be trained to use common laboratory equipment and minimize exposure to hazards.\u00A0\u00A0 Desktop or laptop computer work is also a major component of the job. This is a fully onsite role.\u00A0 The position may require occasional non-routine work hours support.\u00A0Education\u2022\u00A0\u00A0\u00A0 Bachelor\u2019s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.\u2022\u00A0\u00A0\u00A0 A Master\u2019s Degree in a related field is desirable, but not required.
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.
\u00A0
Who We Are
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.
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.
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 \u2013 people with the right technical expertise and a relentless drive to solve real problems \u2013 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we\u2019ve 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.
", "hiringOrganization": "BioMarin Pharmaceutical Inc.", "employmentType": "Fulltime-Regular", "industry": "Quality", "identifier": "o6ulAfwf", "jobLocation": [ { "@type": "Place", "address": { "@type": "PostalAddress", "addressLocality": "Novato", "addressRegion": "California", "addressCountry": "United States" } } ], "title": "Research Associate 1, Analytical Services", "baseSalary": { "@type": "MonetaryAmount", "currency": "", "value": { "@type": "QuantitativeValue", "minValue": "", "maxValue": "", "unitText": "" } } } Research Associate 1, Analytical Services Location: Novato, California Category: Quality Apply Description About Technical Operations BioMarin’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 BioMarin’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. Research Associate, Analytical Services JOB DESCRIPTION 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 BioMarin’s 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. 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. 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. RESPONSIBILITIESResponsibilities include, but are not limited to the following: Method Qualification, Validation, Transfer and Optimization• 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.• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams• Support the maintenance of method and analytical equipment performance• Trend, analyze and interpret analytical results.• Conduct data review and sign-off in applicable document and data management systems• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process Regulatory Compliance, Audit and Site Support• 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.)• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives Cross-Functional Support• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing Process Improvement and Training• Act as technical resource (SME) to train other Analysts in areas of expertise• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance. Required Skills:• 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.• Ability to analyze and interpret data.• Good written and oral communication skills, with the ability to communicate complex information.• Strong organizational skills with the ability to effectively multi-task and prioritize.• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment. Desired Skills:• Experienced in method development, qualification, and transfer.• Knowledge of biopharmaceutical development is a plus.• Experience working in a cross-functional environment. Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support. Education• Bachelor’s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.• A Master’s Degree in a related field is desirable, but not required.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. Who We Are 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.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.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 – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve 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. Apply Apply Later ← Back to Current Openings Share lang: en_US Share LinkedIn Facebook Twitter Email
Research Associate 1, Analytical Services
Location: Novato, California Category: Quality
Location: Novato, California
Location:
Category: Quality
Category: