Associate Director, Formulation Development

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Annual bonus

401(k) matching

PTO 20 days

Personal days

Holidays 11

Benefits package

Employee discount

Wellbeing rewards

Career growth

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks an Associate Director, Formulation Development to lead a team of scientists, align with regulatory requirements, and drive product development from formulation through stability studies.

You will manage tech transfer, scale-up, CRO partnerships, and cross-functional collaboration, review technical documents, monitor budgets, and push innovative drug-delivery approaches for U.S. markets.

Qualifications

• Master’s degree in Pharmaceutics or related field with 12+ years in pharma, incl. 8+ in formulation development for U.S. products.
• Proven track record of submitting 25+ ANDAs.
• Proven track record supporting CMC development through regulatory approval.
• Experience leading scientific teams in a matrix environment.
• Strong planning and organizing skills; adaptable to changing priorities.
• Expert in working to cGMP standards.

Responsibilities

• Lead formulation development team and manage strategy.
• Oversee end-to-end product development and tech transfer.
• Ensure regulatory compliance and quality standards.
• Budget management and resource optimization.
• Collaborate with cross-functional groups.
• Review technical documents and reports.

Skills

Leadership

Team management

Regulatory knowledge

cGMP expertise

Education

Master’s degree in Pharmaceutics, Pharmaceutical Sciences or related field

Ph.D. with 10+ years of relevant experience

Job description

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Title: Associate Director, Formulation Development

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 forleading 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.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s HumanResources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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.

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