Associate Director, Formulation Development

Job Title:      Associate Director, Formulation Development

Location:      Columbus, OH

Job Type:     Full time

Req ID:          6621

 

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 750 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 8,500+ 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 a team of Formulation Development staff in the development of manufacturable, stable, bioequivalent, and patent non-infringing pharmaceutical dosage forms; reviews and assesses active pharmaceutical technical packages, performs development studies in support of formulation development, evaluates data generated from formulation studies, recommends critical processing parameters, manufacturing processes and proposed specifications.

 

Key Responsibilities:

• Leads Formulation Development Team (Managers/Section Heads/Scientists and/or Technicians in Development of dosage forms (NDA, ANDA, Value Proposition Products) from initiation to filing to meet business goals.  Develops formulations as needed.
• Make sound technical recommendations regarding projects/issues and provide analysis of key experimental parameters. Independently select techniques and procedures to solve problems within the discipline of analytical chemistry and product development.
• Review and assess active pharmaceutical technical packages, and work with suppliers to resolve technical related issues (e.g. impurity levels, DMF status, analytical method exchanges).
• Effectively contribute solid technical knowledge on a variety of projects to functional or project teams.
• Maintain knowledge of relevant safety requirements while building knowledge of other regulatory requirements related to R & D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

 

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:

• B.S. in Pharmaceutics or related science (pharmacy, chemistry or engineering is preferred) with at least 12 years of relevant experience
• M.S. in Pharmaceutics or related scientific discipline with 10 years of relevant experience
• Ph.D. (Preferably in Pharmaceutics) with at least 8 years of relevant experience

 

Relevant experience:

 

Relevant experience in the pharmaceutical industry including demonstrated work experience with analytical, product development, commercialization, troubleshooting or equivalent experience.

 

Skills:

• Ability to lead teams within the organization and represent department internally and externally.
• Expert in formulation development including complicated dosage forms.
• Proven ability to manage and supervise management, (managers/section heads), formulation scientists and/or technicians.
• Extensive knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals.
• Ability to process and make conclusions quickly.
• Ability to manage risk and be accountable for projects/personnel under sup