Principal Scientist, Formulation Development

Job Title: Sr. Associate Scientist, Formulation Development - Injectables

Location: Cherry Hill, NJ

Job Type: Full time

Req : 10962

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 it.

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 Sr. Associate Scientist, Formulation Development – Injectables to join our team.

In this role, you will be responsible for leading the development aspects of the standard and specialty/highly complex injectables dosage forms within the Hikma R&D Pipeline. Demonstrated ability to develop products that are stable, meet bioequivalence standards, and robust/manufacturable according to the defined Intellectual Property (IP) strategy. Development must be performed under the highest quality standards and under defined and condensed timelines.

Utilizes Quality by Design principles and tools to develop robust products. Provides technical mentorship for formulation scientists and technicians within the PD Laboratory and external departments.

• Independently leads, develops, and/or troubleshoots complex new formulations and processes from inception through scale-up.
• Experienced in development of differentiated/specialty injectables dosage forms including combination products. Development efforts may be undertaken within Hikma local/ global network or third party contract organizations.

• A high sense of urgency, attention to detail and results orientation is required.
• Experience in the use of QBD principles and tools (such as statistical software, in vitro/in vitro correlation techniques)

• Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, cGMP’s, FDA Developmental and Combination Product guidelines. Leads critical review of the requirements and develops strategies to address for pipeline products.

• Demonstrates leadership and critical thinking skills in the management of projects to independently direct the execution of project milestones.

• Mentors formulation scientists and technicians within Product Development in drug development strategies including formulation principles/techniques, Intellectual Property, Process robustness, In vitro-in vivo correlation and Experimental design/statistical analysis.
• Serves as SME in technical aspects of pipeline and commercial products as needed within the Hikma Network.

• Keeps abreast of current developmental trends and techniques. Serves on internal and external committees/cross‑functional teams regarding formulation development.

• Researches and facilitates the addition of new technology and ideas to expand the development pipeline across the Hikma Network.

• Leads the identification and development of intellectual property opportunities for projects assigned. Assists others in formation of strategies within the product development department.

• Other duties as assigned.

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:

• Bachelor’s degree in chemistry and a minimum 10 years of relevant hands‑on formulation experience; or
• Master’s degree in chemistry or other scientific discipline and 8 years of relevant hands‑on formulation experience; or
• PhD in chemistry or other scientific discipline and 6 years of relevant hands‑on formulation…