Associate Director, Formulation Development
Listed on 2026-08-02
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Business
Regulatory Compliance Specialist
Job Title: Associate Director, Formulation Development
Location: Columbus, OH
Job Type: Full time
About UsAs 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.
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 Associate Director, Formulation Development, to join our team.
Strategy & Leadership- Contribute to and implement R&D strategy aligned with organizational goals.
- Set team objectives, manage performance, and lead cross-functional collaboration.
- Oversee end-to-end product development and project execution (scope, timeline, cost, quality).
- Support technology transfer, scale-up, and commercialization activities.
- Lead investigations, root cause analysis, and corrective actions.
- Develop, implement, and improve R&D policies, processes, and procedures.
- Ensure adherence to regulatory, safety, and quality standards.
- Develop, coach, and motivate team members to maximize performance and capability.
- Prepare and monitor departmental budget; identify cost optimization opportunities.
- Drive process improvements, efficiency, and adoption of new technologies.
- Ensure accurate and timely reporting to management on progress and performance.
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:
- Master’s degree in Pharmaceutics, Pharmaceutical Sciences, or a related field, with at least 12 years of relevant pharmaceutical industry experience, including a minimum of 8 years of progressively responsible formulation development experience supporting products for the U.S. market.
- Proven track record of submitting at least 25+ ANDAs.
- Proven track record supporting CMC development through regulatory approval.
- Experience leading scientific teams in a matrix environment.
- Strong planning and organizing skills and adaptable to changing priorities.
- Expert in working to cGMP standards is essential.
- Master’s in Pharmaceutics, Pharmaceutical Sciences or related disciplines with 15+ years of relevant experience
- Ph.D. with 10+ years of relevant experience.
- Experience with advanced/novel drug delivery or formulation technologies (e.g., complexation, hot melt extrusion, spray drying) is a strong advantage.
- 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
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
- Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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