Combination Product Expert
We are seeking a senior Combination Product Expert to provide strategic and technical guidance on a novel cannabis micro‑dosing inhaler. This contract role focuses on the integration of drug formulation, inhaler device design, manufacturing processes, and overall product performance, with the objective of achieving pharma‑grade safety, consistency, and reliability.
A functional prototype already exists, and the goal of this engagement is to de‑risk the product as it advances toward scale and commercialization. The expert will serve as a critical advisor, helping align formulation behavior with device architecture while identifying and mitigating cross‑functional risks across engineering, manufacturing, and quality domains.
Scope of Work
- Evaluation and optimization of the device-drug interface, including formulation behavior within the inhaler system
- Assessment and improvement of dose accuracy, consistency, and reproducibility across use conditions
- Review of materials compatibility (formulation, device, seals, and airflow pathways)
- Guidance on in‑device stability and shelf life, including storage and real‑world use considerations
- Identification of cross‑functional risks spanning formulation, device, manufacturing, quality, and user interaction
- Advisory input on testing strategies, performance criteria, and failure‑mode analysis
Ideal Candidate Profile
- Extensive experience with drug-device combination products, ideally inhalers or pulmonary delivery systems
- Background in pharmaceutical, medical device, or regulated consumer health product development
- Strong understanding of inhalation science, dose delivery mechanisms, and systems‑level design trade‑offs
- Experience collaborating across R&D, engineering, manufacturing, and quality teams
- Ability to provide clear, pragmatic guidance appropriate for a developing product transitioning toward scale
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