Senior Product Development Chemist

Develop and draft new product protocols or formula ID’s with minimal supervision.

Assist in drafting Product Development protocols and summary reports.

Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e.

FDA).

Collect and manage technical information, including safety data sheets and technical data sheets for new molecules and products.

Responsible for performing investigations related to OOS laboratory testing.

Conduct trials for the development of new products and the improvement of existing formulations.

Conducting experiments, generating data, assisting in data analysis, preparing sample.

Troubleshoot technical, formulation, and processing issues during product development and commercialization.

Define the requirements for the manufacture of pilot batches, as well as the quantity of product units intended for the execution of accelerated and natural stability.

Define the product specifications and the stability indicator specifications, as well as the conditions for carrying out these studies.

Coordinate the technological transfers of new products towards production, assembly and quality assurance.

Include batching several iterations, ensuring technical accuracy in product development through stability studies, and documentation.

Identification and characterization of the unknown impurities in the drug products and drug substances.

Manages R&D project activities by accurately collecting, recording, maintaining, and reporting scientific data.

HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, and Particle Size Distribution (PSD).

Collaborates with internal groups to determine and implement preventative measures to reduce/eliminate repetitive deviations.

Education and Experience required: Bachelor’s degree or equivalent in Chemistry or Pharmaceutical Sciences or a related field plus 5 years of progressive experience job offered as or Analyst or Chemist.

In lieu of Bachelor’s degree and 5 years’ experience will accept Master’s degree in Chemistry or Pharmaceutical Sciences or a related field plus 2-year experience in job offered or as Analyst or Chemist.

Prior work experience must include 2 years’ experience in collecting and managing technical information, including safety data sheets and technical data sheets for new molecules and products, performing investigations related to testing.

Conducting trials for the development of new products and the improvement of existing formulations.

Conducting experiments, generating data, assisting in data analysis, preparing sample.

Troubleshoot technical, formulation, and processing issues during product development and commercialization.