Associate Director, Formulation Development

RXinsider LTD.; Columbus (OH); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) match

PTO starting at 20 days

Personal days

Company paid holidays

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks an Associate Director, Formulation Development to lead a team of scientists and drive end-to-end formulation development for US-market products.

You will oversee scale-up, tech transfer, stability studies, and regulatory alignment with cross-functional partners. The role requires a strong track record in pharma formulation development, leadership, and deep cGMP expertise, with responsibilities spanning budget, timelines, and external

Qualifications

• Master’s degree in Pharmaceutics, Pharmaceutical Sciences, or related field and 12+ years in pharma.
• Experience leading formulation development for US-market products.
• Proven track record submitting 25+ ANDAs and supporting CMC through regulatory approval.

Responsibilities

• Lead and manage a team of formulation scientists.
• Oversee end-to-end formulation development, scale-up, tech transfer, and stability studies.
• Ensure compliance with cGMP, safety, and environmental standards; manage budgets and external partnerships.

Skills

Leadership

Team management

Regulatory knowledge

Project management

cGMP expertise

Education

Master’s degree in Pharmaceutics/Pharmaceutical Sciences

Ph.D. in related discipline

Job description

Job Title

Associate Director, Formulation Development

Location

Columbus, OH

Job Type

Full time

Req ID

12008

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 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.

Key Responsibilities

Strategy & Leadership

• Contribute to and implement R&D strategy aligned with organizational goals.
• Set team objectives, manage performance, and lead cross-functional collaboration.

Operations & Projects

• 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.

Policies & Compliance

• Develop, implement, and improve R&D policies, processes, and procedures.
• Ensure adherence to regulatory, safety, and quality standards.

People Management

• Develop, coach, and motivate team members to maximize performance and capability.

Financial Management

• Prepare and monitor departmental budget; identify cost optimization opportunities.

Continuous Improvement & Innovation

• Drive process improvements, efficiency, and adoption of new technologies.

Reporting

• Ensure accurate and timely reporting to management on progress and performance.

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:

• 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.

Preferred Qualifications

• 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.

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% 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.

Equal Opportunity Employer

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.