Sr. Scientist, Drug Delivery- Onsite in Aliso Viejo

Glaukos•Aliso Viejo, CA

1d•$97,900 - $122,400•Onsite

About The Position

The Sr. Scientist, Drug Delivery will lead the design, development, and optimization of novel drug delivery systems, including sustained-release and controlled-release dosage forms. This role involves developing targeted and sustained drug delivery formulations using advanced technologies, designing and executing studies to characterize drug release kinetics and formulation stability, and evaluating structure-property relationships. The scientist will also select and characterize raw materials, develop robust and scalable manufacturing processes, apply Quality by Design principles, lead technical troubleshooting, and support process scale-up and technology transfer. Additionally, the role provides scientific and technical leadership across drug delivery programs, acts as a subject matter expert, identifies technical risks, and evaluates emerging technologies. Collaboration with cross-functional teams, authoring of regulatory documents, and support for health authority questions are key aspects. The scientist will also mentor junior staff and ensure compliance with quality systems and safety requirements.

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

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 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.
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.
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.
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 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.