Job Description

What You’ll Do:

Drug Delivery and Formulation Development

• Lead the design, development, and optimization of novel drug delivery systems, including sustained-release and controlled-release dosage forms.
• Develop targeted and sustained drug delivery 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 that influence drug loading, release behavior, stability, manufacturability, and product quality.
• Select and characterize excipients, polymers, active pharmaceutical ingredients, and other critical raw materials.

Process Development and Scale-Up

• Develop robust and scalable formulation and manufacturing processes to support preclinical, clinical, and commercial supply.
• Apply Quality by Design and Design of Experiments principles to identify critical material attributes, critical process parameters, and critical quality attributes.
• Lead technical troubleshooting and root-cause investigations for formulation, process, and product-performance challenges.
• Support process scale-up, technology transfer, process characterization, and validation activities with internal teams and external manufacturing partners.
• Provide technical leadership for hot melt extrusion process development and optimization when applicable.

Scientific Leadership and Innovation

• Provide scientific and technical leadership across multiple drug delivery programs, influencing platform strategy, development priorities, and key 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.

Cross-Functional Collaboration and Regulatory Support

• 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.

Mentorship and Compliance

• Mentor junior scientists and research associates and provide guidance on 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.

How You’ll Get There:

Required Qualifications

• PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science, Polymer Science, Chemistry, Biochemistry, or a related scientific discipline with 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.

PREFERRED QUALIFICATIONS

• 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.
• This role is based onsite in Aliso Viejo, CA.

CORE COMPETENCIES

• Scientific rigor and sound independent judgment
• Hands-on technical leadership and accountability
• Innovation and practical problem solving
• Cross-functional partnership and influence
• Clear technical communication
• Mentorship and talent development
• Commitment to quality, compliance, and patient-focused outcomes

#GKOS

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

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.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.