Sr. Scientist, Drug Delivery

Glaukos•Aliso Viejo, CA

1d•$97,900 - $122,400•Onsite

About The Position

The Sr. Scientist, Drug Delivery leads development of novel drug delivery systems and formulations, including sustained- and controlled-release dosage forms. The role develops targeted and sustained formulations using technologies such as polymeric matrices, implants, microparticles, nanoparticles, and hydrogels, and designs studies to characterize release kinetics, stability, material properties, and product performance. It evaluates structure-property relationships and selects and characterizes excipients, polymers, active pharmaceutical ingredients, and other critical raw materials. The position develops scalable formulation and manufacturing processes for preclinical, clinical, and commercial supply, applying Quality by Design and Design of Experiments principles. It leads troubleshooting and root-cause investigations and supports scale-up, technology transfer, process characterization, and validation with internal teams and external manufacturing partners. The role also provides technical leadership for hot melt extrusion process development and optimization when applicable. The Sr. Scientist provides scientific leadership across drug delivery programs, serves as a subject matter expert in sustained-release technologies and formulation science, identifies technical risks and mitigation strategies, evaluates emerging technologies, and contributes to intellectual-property activities. The role collaborates across CMC, analytical development, nonclinical, clinical, regulatory, quality, engineering, and manufacturing functions; prepares technical documents and regulatory submission content; supports health authority responses; and manages technical interactions with external partners. It mentors junior staff and maintains documentation and compliance with applicable quality systems, cGMP expectations, safety requirements, and internal procedures. This role is based onsite in Aliso Viejo, California. Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on therapies for glaucoma, corneal disorders, and retinal diseases. The company describes its mission as developing novel therapies that can advance care and improve the lives of patients with chronic, sight-threatening eye diseases.

Requirements

PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science, Polymer Science, Chemistry, Biochemistry, or a related scientific discipline.
0–4+ years of relevant pharmaceutical, biotechnology, medical device, or combination product development experience, including substantial experience in drug delivery and formulation development.
Demonstrated expertise in sustained-release or controlled-release drug delivery technologies.
Experience leading formulation and process development from early feasibility through scale-up and technology transfer.
Strong working knowledge of polymer science, material characterization, drug-release testing, stability assessment, and pharmaceutical development principles.
Ability to independently design experiments, analyze complex data, draw scientifically sound conclusions, and recommend next steps.
Excellent technical writing, presentation, collaboration, and problem-solving skills.

Nice To Haves

PhD in a related scientific discipline with 4+ years of experience.
Hands-on industrial experience with hot melt extrusion, injection molding, and hydrogel processing, including formulation development, equipment selection, process optimization, scale-up, and troubleshooting.
Experience developing ophthalmic drug products, long-acting delivery systems, implants, inserts, or combination products.
Experience with polymer-based drug delivery systems and characterization of solid dispersions or extrudates.
Knowledge of cGMP manufacturing, process validation, and technology transfer requirements.
Experience supporting IND, IMPD, NDA, or other global regulatory submissions.
Track record of publications or significant scientific contributions in drug delivery.

Responsibilities

Lead the design, development, and optimization of novel drug delivery systems, including sustained-release and controlled-release dosage forms.
Develop targeted and sustained formulations using polymeric matrices, implants, microparticles, nanoparticles, hydrogels, and other advanced delivery technologies.
Design and execute studies to characterize drug release kinetics, formulation stability, material properties, and product performance.
Evaluate structure-property relationships affecting drug loading, release behavior, stability, manufacturability, and product quality.
Select and characterize excipients, polymers, active pharmaceutical ingredients, and other critical raw materials.
Develop robust, scalable formulation and manufacturing processes for preclinical, clinical, and commercial supply.
Apply Quality by Design and Design of Experiments principles to identify critical material attributes, process parameters, and quality attributes.
Lead technical troubleshooting and root-cause investigations for formulation, process, and product-performance challenges.
Support scale-up, technology transfer, process characterization, and validation with internal teams and external manufacturing partners.
Provide technical leadership for hot melt extrusion process development and optimization when applicable.
Provide scientific and technical leadership across drug delivery programs and influence platform strategy, development priorities, and project decisions.
Serve as a subject matter expert in sustained-release technologies, formulation science, and pharmaceutical drug delivery.
Identify technical risks, recommend mitigation strategies, and communicate development options to cross-functional teams and leadership.
Evaluate emerging technologies and translate relevant scientific advances into practical development strategies.
Contribute to invention disclosures, patent applications, publications, and other intellectual-property activities.
Partner with CMC, Analytical Development, Nonclinical, Clinical Development, Regulatory Affairs, Quality, Engineering, and Manufacturing to align technical plans with program objectives.
Author and review protocols, technical reports, development summaries, presentations, and CMC sections of regulatory submissions.
Support responses to health authority questions related to formulation, process development, characterization, and product performance.
Manage technical interactions with consultants, contract research organizations, contract development and manufacturing organizations, and other external partners.
Mentor junior scientists and research associates in experimental design, data interpretation, documentation, and scientific communication.
Maintain complete, accurate, and timely laboratory records and development documentation.
Ensure activities comply with applicable quality systems, cGMP expectations, safety requirements, and internal procedures.