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.

✓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

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