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Director, Formulation Development – Respiratory, Nasal & Semi-Solid Liquids
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research, Pharmaceutical Manufacturing
Job Description & How to Apply Below
Responsibilities
- Regular and predictable onsite attendance and punctuality.
- Lead formulation development for multiple inhalation (MDIs, DPIs, nebulized products), intranasal sprays and drops, semi‑solids (topicals, gels, creams, ointments) plus liquid oral and topical products.
- Define and execute formulation strategies aligned with product quality, manufacturability, and regulatory expectations.
- Provide technical leadership on QbD, risk assessments, and control strategies.
- Partner closely with Analytical, Device Development, Process Development, Clinical, Quality, and Regulatory Affairs.
- Support preparation and review of CMC sections for INDs, NDAs/ANDAs, and global regulatory submissions.
- Lead troubleshooting and scientific root‑cause analysis for formulation and stability issues.
- Build, mentor, and develop high‑performing formulation teams.
- Evaluate new technologies and approaches to enhance complex product differentiation.
- Own the formulation department budget, ensuring optimal allocation of resources to strategic initiatives.
- Monitor financial performance and ensure efficient use of funds across programs and scientific operations.
- Bachelors Degree with relevant experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
- Masters Degree with relevant experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
- 12+ years of progressive experience in formulation development.
- 2 years of experience with hands on expertise in respiratory and/or nasal drug delivery, strong experience with semi solid and liquid formulations.
- Proven track record supporting CMC development through regulatory approval.
- Prior experience leading scientific teams in a matrix environment.
- Communication must be appropriate, timely, and accurate.
- Strong planning and organizing skills & adaptable to changing priorities.
- Expert in working to cGMP standards is essential.
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