Associate Director, Formulation Development

HIKMA•Columbus, OH

8d•Onsite

About The Position

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. 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.
Manage external partnerships (e.g., CROs) to ensure quality and timelines.