Glaukos Corporation
Sr Scientist II / Principal Scientist - Drug Delivery Innovation
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Overview
Sr Scientist II / Principal Scientist - Drug Delivery Innovation at Glaukos Corporation. This role focuses on developing pharmaceutical drug products and drug device combinations for ophthalmic disease within the Drug Delivery Innovations team. What You’ll Do
Lead and contribute to the development of ophthalmic drug products and drug-device combinations. Multitask across projects and disciplines with excellent written and verbal communication skills (drug product development reports, presentations, scientific communications). Allocate 60–70% of time to laboratory work; remaining time to data analysis, report generation, training, and team/project meetings. Serve as a scientific leader and technical expert in pharmaceutical product development, with a focus on delivery systems (e.g., biodegradable polymers, core/shell release systems, hydrogel formulations, and related dosage forms). Provide expertise in intraocular delivery and drug substance stability testing, sterilization, filling devices, inspection, and transportation for combination products (in collaboration with internal teams and CROs). Develop and validate dissolution methodologies; contribute to analytical method development for potency, stability, impurity testing, and aggregation profiling. Apply quality by design (QbD) principles to determine and characterize critical quality attributes for drug-device combinations. Support regulatory activities with knowledge of GMP drug development, Design Controls for medical devices, and preparation of CMC sections for IND/NDA submissions. Evaluate contract research and manufacturing organizations; manage technology transfer, scale-up, and validation activities for commercial drug product processing (sterile processing, process characterization). Operate analytical instruments (e.g., HPLC, FTIR) and relevant techniques (diffusion cells, hot-melt extrusion, microscopy) as part of formulation development. Demonstrate strong understanding of intraocular and systemic pharmacokinetics and sterile product development regulatory requirements. Bring problem-solving, initiative, and clear communication to the team; typically 7+ years of formulation development experience, with experience in protein drug delivery systems. Develop and transfer assays to QC environments; characterize formulation methods and potency assays; contribute to product development from research through clinical evaluation to regulatory approval. Qualifications
Bachelor’s or Master’s in Chemistry, pharmaceutical sciences, physical-organic chemistry, chemical engineering, biochemistry, or a related field. 7+ years of experience applying fundamental scientific principles to formulation development. Experience with drug delivery systems, especially ophthalmic/intraocular delivery; proficiency in polymer science, chemistry, and pharmaceutical product development. Experience with protein drug delivery systems and development/transfer of analytical assays to QC environments. Strong knowledge of GMP, Design Control, and regulatory documentation related to IND/NDA (CMC sections). Ability to work independently and collaboratively across functions; strong communication and leadership skills. #GKOSUS
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Sr Scientist II / Principal Scientist - Drug Delivery Innovation at Glaukos Corporation. This role focuses on developing pharmaceutical drug products and drug device combinations for ophthalmic disease within the Drug Delivery Innovations team. What You’ll Do
Lead and contribute to the development of ophthalmic drug products and drug-device combinations. Multitask across projects and disciplines with excellent written and verbal communication skills (drug product development reports, presentations, scientific communications). Allocate 60–70% of time to laboratory work; remaining time to data analysis, report generation, training, and team/project meetings. Serve as a scientific leader and technical expert in pharmaceutical product development, with a focus on delivery systems (e.g., biodegradable polymers, core/shell release systems, hydrogel formulations, and related dosage forms). Provide expertise in intraocular delivery and drug substance stability testing, sterilization, filling devices, inspection, and transportation for combination products (in collaboration with internal teams and CROs). Develop and validate dissolution methodologies; contribute to analytical method development for potency, stability, impurity testing, and aggregation profiling. Apply quality by design (QbD) principles to determine and characterize critical quality attributes for drug-device combinations. Support regulatory activities with knowledge of GMP drug development, Design Controls for medical devices, and preparation of CMC sections for IND/NDA submissions. Evaluate contract research and manufacturing organizations; manage technology transfer, scale-up, and validation activities for commercial drug product processing (sterile processing, process characterization). Operate analytical instruments (e.g., HPLC, FTIR) and relevant techniques (diffusion cells, hot-melt extrusion, microscopy) as part of formulation development. Demonstrate strong understanding of intraocular and systemic pharmacokinetics and sterile product development regulatory requirements. Bring problem-solving, initiative, and clear communication to the team; typically 7+ years of formulation development experience, with experience in protein drug delivery systems. Develop and transfer assays to QC environments; characterize formulation methods and potency assays; contribute to product development from research through clinical evaluation to regulatory approval. Qualifications
Bachelor’s or Master’s in Chemistry, pharmaceutical sciences, physical-organic chemistry, chemical engineering, biochemistry, or a related field. 7+ years of experience applying fundamental scientific principles to formulation development. Experience with drug delivery systems, especially ophthalmic/intraocular delivery; proficiency in polymer science, chemistry, and pharmaceutical product development. Experience with protein drug delivery systems and development/transfer of analytical assays to QC environments. Strong knowledge of GMP, Design Control, and regulatory documentation related to IND/NDA (CMC sections). Ability to work independently and collaboratively across functions; strong communication and leadership skills. #GKOSUS
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