Glaukos Corporation
Bioanalytical Sr. Scientist I
Glaukos Corporation, San Clemente, California, us, 92674
How will you make an impact?
Glaukos is a medical technology and pharmaceutical company that's advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market-leader iStent inject W), corneal disorders and retinal diseases.
Glaukos is looking for a motivated bioanalytical scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team develops and executes the nonclinical and clinical ADME strategy for our novel pharmaceutical products. The team is also responsible for developing and performing liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays to assess local biodistribution, systemic exposure, and quantitation of small molecules and metabolites in biological fluids and tissues.
A successful candidate will contribute to internal method development and quantitation efforts and will manage external activities at CROs to provide timely bioanalytical support for Research and Development project teams. This candidate will demonstrate excellent collaboration and communication skills while serving as a subject matter expert advising colleagues from the Applied Research and Translational Sciences group (and other relevant departments) how LC-MS/MS techniques may address key project questions. The ideal candidate would be versatile, self-motivated, timeline and process oriented and demonstrate independent method development skills and the ability to troubleshoot.
What will you do?
Independently perform hands on LC-MS/MS method development, method optimization, fit-for-purpose qualification and non-regulated (non-GLP) bioanalytical sample analysis in a variety of biological fluids and tissues in a timely manner. Coordinate with and monitor external CROs on method development, qualification, validation and sample analysis to enable PK/PD, GLP Tox, and clinical PK studies. Write formal study reports and bioanalytical sections of regulatory documents for submission to regulatory agencies. Maintain awareness and implement state-of-the-art technologies and methodologies (both within and outside field of expertise) that enhance the department's ability to answer key research and development questions. Maintain state-of-the-art lab equipment (e.g. LC-MS/MS instruments). Closely collaborate with colleagues in the non-clinical development organization and other relevant departments. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
How will you get here?
Bachelor's degree in chemistry or a closely related discipline, and a minimum of 8+ years related experience, or Master's degree and 6+ years of experience, or PhD and 4+ years of experience. Hands-on experience with development and non-regulated (non-GLP) qualification of LC-MS bioanalytical methods for small molecule drugs and peptides using various techniques (LLE, SPE and immunoprecipitation) in biological fluids and tissues. Extensive hands-on experience developing and qualifying LC-MS/MS-based bioanalytical assays to support a variety of modalities including small molecules, peptides, and biologics. Familiarity with GLP regulations and bioanalysis-associated FDA and ICH guidances. Experience in collaborating with, transferring, and monitoring CRO method development, validation, and sample analysis (both non-GLP and GLP) activities to ensure timely delivery of data to project teams. Strong verbal and written communication skills. Strong organizational skills and keen attention to detail; ability to handle multiple projects in a fast-paced environment. Proven ability to work independently and to collaborate cross-functionally to accomplish goals in a timely manner. Basic understanding of pharmacokinetics and drug metabolism is desired.
Preferred Experience:
Familiarity with Sciex LC-MS/MS systems and software. Additional knowledge of ligand binding assays (e.g. ELISA) is helpful.
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family. Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years! Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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Glaukos is a medical technology and pharmaceutical company that's advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market-leader iStent inject W), corneal disorders and retinal diseases.
Glaukos is looking for a motivated bioanalytical scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team develops and executes the nonclinical and clinical ADME strategy for our novel pharmaceutical products. The team is also responsible for developing and performing liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays to assess local biodistribution, systemic exposure, and quantitation of small molecules and metabolites in biological fluids and tissues.
A successful candidate will contribute to internal method development and quantitation efforts and will manage external activities at CROs to provide timely bioanalytical support for Research and Development project teams. This candidate will demonstrate excellent collaboration and communication skills while serving as a subject matter expert advising colleagues from the Applied Research and Translational Sciences group (and other relevant departments) how LC-MS/MS techniques may address key project questions. The ideal candidate would be versatile, self-motivated, timeline and process oriented and demonstrate independent method development skills and the ability to troubleshoot.
What will you do?
Independently perform hands on LC-MS/MS method development, method optimization, fit-for-purpose qualification and non-regulated (non-GLP) bioanalytical sample analysis in a variety of biological fluids and tissues in a timely manner. Coordinate with and monitor external CROs on method development, qualification, validation and sample analysis to enable PK/PD, GLP Tox, and clinical PK studies. Write formal study reports and bioanalytical sections of regulatory documents for submission to regulatory agencies. Maintain awareness and implement state-of-the-art technologies and methodologies (both within and outside field of expertise) that enhance the department's ability to answer key research and development questions. Maintain state-of-the-art lab equipment (e.g. LC-MS/MS instruments). Closely collaborate with colleagues in the non-clinical development organization and other relevant departments. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
How will you get here?
Bachelor's degree in chemistry or a closely related discipline, and a minimum of 8+ years related experience, or Master's degree and 6+ years of experience, or PhD and 4+ years of experience. Hands-on experience with development and non-regulated (non-GLP) qualification of LC-MS bioanalytical methods for small molecule drugs and peptides using various techniques (LLE, SPE and immunoprecipitation) in biological fluids and tissues. Extensive hands-on experience developing and qualifying LC-MS/MS-based bioanalytical assays to support a variety of modalities including small molecules, peptides, and biologics. Familiarity with GLP regulations and bioanalysis-associated FDA and ICH guidances. Experience in collaborating with, transferring, and monitoring CRO method development, validation, and sample analysis (both non-GLP and GLP) activities to ensure timely delivery of data to project teams. Strong verbal and written communication skills. Strong organizational skills and keen attention to detail; ability to handle multiple projects in a fast-paced environment. Proven ability to work independently and to collaborate cross-functionally to accomplish goals in a timely manner. Basic understanding of pharmacokinetics and drug metabolism is desired.
Preferred Experience:
Familiarity with Sciex LC-MS/MS systems and software. Additional knowledge of ligand binding assays (e.g. ELISA) is helpful.
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family. Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years! Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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