Product Development Formulator

Company Description

Garonit Pharmaceutical is a US-based multinational company owned by Rohit and Nitin Garg, with headquarters in New Jersey. The company serves Fortune 500 companies and small-scale industries across North America, LATAM, and EMEA. Garonit Pharmaceuticals is known for its quality operations on a global platform while maintaining a local customer focus. Our manufacturing plants in New Jersey are cGMP and US-FDA compliant, with warehouses in Germany and the UK.

Role Description

This is a full-time on-site role for a Product Development Formulator at Garonit Pharmaceutical in Fairfield, NJ. The Product Development Formulator will be responsible for formulating pharmaceutical liquid products. Document work and prepare Product Development Reports and other documents needed for FDA filing. This is a hands-on position and will be performing the formulation experiments, determining appropriate testing, analyzing results and preparing next steps.

·      Research patents and literature for supporting information to the projects.

·      Under the direction of the President, perform experiments and trials to develop finished products for filing ANDAs and NDAs to the FDA.

·      Work in the R&D and QC Laboratory to perform the formulation work.

·      Write documents required for submission such as the Product Development Report and Quality Operations Summary.

·      Evaluate and specify raw materials to be used.

·      Develop tentative raw material, in process, finished product and stability specifications.

·      Other duties assigned by Management.

Qualifications

Minimum of a Bachelor’s degree in a scientific discipline (Chemistry preferred). Experienced in liquid formulations

Experience working in an FDA regulated environment

Knowledge of USP Monograph testing, method development & validation

Knowledge of CFR & ICH Regulatory Guidelines

Knowledge of cGMP processes and lab safety

Ability to perform patent research as well as appropriate literature research.

Other Qualifications

·      Has technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory.

·      Has technical knowledge of liquid product development procedures, material compatibility studies, etc.

·      In depth knowledge of all laboratory equipment, practices, and procedures

·      Problem analysis, solving and resolution skills

·      Has excellent oral and written skills

·      Has excellent interpersonal skills

·      Is self motivated

·      Has a very high attention to detail

·      Has a positive attitude

Must speak, read, and write in English