Director, Formulation Development; Respiratory, Nasal & Semi‑Solid Liquids

Position: Director, Formulation Development (Respiratory, Nasal & Semi‑Solid Liquids)
Job Title:

Director, Formulation Development (Respiratory, Nasal & Semi‑Solid Liquids)

Location:

Columbus, OH

Job Type: Full time

Req

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Director, Formulation Development (Respiratory, Nasal & Semi‑Solid Liquids) to join our team.

In this role, you will be responsible for scientific and strategic leadership for the formulation development of complex drug products, with a primary focus on respiratory, nasal, semi‑solid, and liquid dosage forms. This role is accountable for formulation strategy from early development through commercialization and serves as a key technical authority across CMC programs. This is a significant opportunity to directly impact the development of safe, cost-effective medicines that will make better health within reach every day.

Key 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.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

* 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.

Preferred Qualifications:

* PhD with relevant experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related discipline.

What We Offer *:

* 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%…