Formulation Development Scientist

Summary:

This position is responsible for product development for oral liquids and parenteral dosage forms including formulation development, scale-up, technology transfer and manufacturing of registration batches to support PAIs portfolio comprising of 505 (j) and 505(b)(2) drug products. Executes assigned tasks within the constraints of timelines and under minimal supervision by senior management.

Responsibilities:

• Design and conduct formulation development, process development and optimization of oral liquids and parenteral formulations.
• Develop a robust and scalable formulation and manufacturing process for oral liquids and parenteral formulations following Quality by Design (QbD) principles.
• Collaborate with other scientists and/or disciplines to design studies related to pre-formulation and formulation of various dosage form products that may impact the stability and delivery of the product.
• Collaborate with management to develop and track project timelines and assumes departmental responsibilities for projects; providing updates as instructed.
• Design and evaluate the development of Critical Process Parameters (CPPs), Quality Target Product Profiles (QTTPs), Critical Quality Attributes (CQAs), and scale-up manufacturing processes.
• Author and review compounding and packaging batch records, protocols, SOPs and reports to support development of PAIs product portfolio.
• Analyze results, organize and create presentations and effectively present findings to senior management, with little to no assistance.
• Supervise the maintenance of the formulation development laboratory, including its instruments and equipment.
• Write experimental designs to carry out process development and evaluation work.
• Generate product development documents in support of regulatory submissions and demonstrate a high level of understanding of drug delivery systems, FDA regulations, and regulatory guidelines.
• Support and/or assumes departmental and/or project responsibilities as assigned/necessary.
• Maintain accurate and comprehensive documentation of experimental activities in lab notebooks.
• Takes ownership in and effectively develops and evaluates proposed formulations and processing procedures
• Moderate to general supervision on day-to-day tasks and new assignments from Supervisor or Manager.

Requirements:

• BS + 7 years of relevant experience or MS +2 years of relevant experience in chemical engineering, chemistry, pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, or relevant field.

• Demonstrate strong understanding of drug delivery systems, FDA regulations, and regulatory guidelines.
• Demonstrate experience in independently designing and conducting experiments and analyzing data.
• Demonstrates excellent problem-solving and data interpretation skills.
• Demonstrates ability to provide solutions to a variety of technical problems of moderate scope and complexity.
• Should be fully conversant with advanced principles of pharmaceutics, physical and organic chemistry, thermodynamics, and materials science.
• Should be experienced with Quality by Design (QbD) principles and applying statistical approaches to design and analysis of experiments.
• Ability to perform complex scientific work independently with no supervision.
• Ability to work in a cross-function environment under aggressive timelines.
• Should have strong verbal and written communication skills.