Glaukos

Sr. Scientist, Drug Delivery- Onsite in Aliso Viejo

Glaukos • $110K — $130K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • PhD in relevant scientific discipline with 0-4+ years of related experience.
  • Expertise in sustained-release or controlled-release drug delivery technologies.
  • Experience leading formulation and process development from feasibility to scale-up.
  • Strong knowledge of polymer science and pharmaceutical development principles.
  • Ability to design experiments and analyze complex data independently.

Responsibilities

  • Lead design and optimization of novel drug delivery systems.
  • Develop targeted drug delivery formulations using advanced technologies.
  • Execute studies to evaluate drug release kinetics and formulation stability.
  • Identify critical material and process attributes using Quality by Design principles.
  • Collaborate with teams for scale-up and technology transfer activities.

Benefits

  • Opportunity for scientific contribution through invention disclosures and publications.
  • Engage in mentorship of junior scientists.
  • Work in a cross-functional environment with diverse teams.
  • Onsite work location in Aliso Viejo, CA.
Full Job Description
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


About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

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