Sr. Scientist, Drug Delivery

Role details

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