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. • PhD in related scientific discipline with 4+ years of experience preferred. • 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