Director, Formulation Development – Respiratory, Nasal & Semi-Solid Liquids
Columbus, Ohio, United States of America
Full Time
2 weeks ago
Visa Sponsor
Key skills
LeadershipCommunication
About this role
Role Overview
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.
Requirements
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.
Benefits
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority