Sr. Associate Scientist, Formulation Development

Job Title:

Sr. Associate Scientist, Formulation Development - Injectables

Location:

Cherry Hill, NJ Job Type: Full time Req

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.

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 developing standard and complex pharmaceutical injectable dosage forms that are stable, bioequivalent to the brand product, and robust/manufacturable according to the defined Intellectual Property (IP) strategy.

Complete Registration Lot manufacture and provide documentation in support of QbD (Quality by Design) principles for the Regulatory Filings.

• Regular and predictable onsite attendance and punctuality.
• Works within project team structure with minimal supervision to develop new formulations for standard and complex injectable dosage forms which may include potent compounds or DEA controlled substances as assigned.
• Continues to increase pharmaceutical development expertise by assisting senior Scientists in development of dosage forms through hands on experiences and formal training.
• Demonstrates knowledge of formulation and processing techniques of process trains and equipment.
• To develop robust, stable, and bioequivalent dosage forms for regulatory filing and launch.
• Generates, collects and reviews data on developmental lots to determine the most optimal formulation and manufacturing process in support of QbD requirements with respect to stability, bioequivalency, robustness and IP strategy.
• Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, and cGMP’s and demonstrates the ability to critically review the requirements.
• Manufacture an adequate amount of developmental lots and study the correct variables to assure success.
• Design moderately complex experiments to obtain required data.
• Demonstrate effective project management skills to facilitate the execution of project milestones.
• Plans, observes, and coordinates the manufacture, packaging, and disposition of the Pilot and Registration Lots.
• Assists and consults during scale-up and validation activities. Supports assigned projects throughout the lifecycle of the product as the demonstrated Subject Matter Expert (SME).
• Generate and/or review the required documentation to justify the formulation and process selected. Obtain the required samples and perform the attendant testing. Record personal observations and provide consultation during the manufacturing and packaging of the Registration, Scale-Up and/or Validation Lots.
• Reviews and collects data on Pilot and Registration Lots. Incorporates the data in the required Technical Reports, including the Pharmaceutical Development Report in support of QbD for the regulatory filings.
• Provide technical input for FDA CMC and DBE deficiencies as required.
• Conducts the proper experiments and collects the appropriate data to justify the product specification and support the approval of the product via the Q /QbD documentation and required regulatory filings.
• Leads tactical teams within the department to accomplish departmental goals.
• Successfully interacts within the department to accomplish project and departmental goals.
• Demonstrates the appropriate team leadership skills to successfully accomplish the task.
• Participates in the development of intellectual…