Role OverviewThe Associate Director, Formulation Development will lead and manage a team of Formulation scientists, overseeing product development activities, including formulation, scale-up, technology transfer, and stability studies. The role requires technical leadership, resolving complex issues, and guiding experimental design and laboratory studies. The Associate Director will also manage cross-functional collaboration to support product development and approvals.
What You Will Do
The main day-to-day responsibilities of the Associate Director, Formulation Development include overseeing end-to-end product development and project execution, supporting technology transfer, scale-up, and commercialization activities, leading investigations, root cause analysis, and corrective actions, and ensuring adherence to regulatory, safety, and quality standards.
Why It Might Be a Fit
The ideal candidate will have a proven track record of submitting ANDAs, supporting CMC development through regulatory approval, and leading scientific teams in a matrix environment. Experience with advanced/novel drug delivery or formulation technologies is a strong advantage.
Requirements
- Master’s degree in Pharmaceutics, Pharmaceutical Sciences, or a related field
- At least 12 years of relevant pharmaceutical industry experience
- 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
Benefits
- Annual performance bonus
- Commission
- Share potential
- Auto enrollment in a Hikma-sponsored 401(k) program
- Generous paid time off (PTO) bank
- 3 personal days
- 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
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
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