Associate Director, Formulation Development
About The Position
We are seeking a talented and motivated Associate Director, Formulation Development, to join our team. In this role, you will be responsible for leading and managing a team of Formulation scientists ensuring alignment with departmental strategy, company vision, and regulatory requirements. Overseeing product development activities, including formulation, scale-up, technology transfer, and stability studies. Provide technical leadership, resolve complex issues, and guide experimental design and laboratory studies. Manage cross-functional collaboration (Portfolio, PMO, Operations, QA, QC, Regulatory etc.) to support product development and approvals. Review and approve technical documents, reports, and specifications. Monitor R&D budget, performance, and resource utilization. Ensure compliance with safety, quality, and environmental standards. Drive innovation, continuous improvement, and adoption of new technologies. Manage external partnerships (e.g., CROs) to ensure quality and timelines.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
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
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Manager
