Sr. Scientist, Drug Delivery- Onsite in Aliso Viejo

What You'll Do: 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

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