Position HR200 Formulations Scientist

Position Summary

Position title will be commensurate with experience.

The formulation Scientist will be responsible for understanding small molecule chemistry, degradation pathways, characterization and stabilization techniques. The selected candidate will be supporting screening formulations for optimizing solubility and stability of drug candidates for ophthalmic and injectable drug products. Develop formulations for preclinical studies. Work with regulatory team in preparing PreIND meeting request and support IND and NDA submissions. Design and conduct pre-formulation, formulation development, process development and process optimization of parenteral and ophthalmic formulations and related alternate drug delivery systems such as solutions, lyophilized products, sterile injectable suspensions etc. Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house. Conduct literature search for the assigned projects. Demonstrate scientific creativity, initiative and contribution to the team and company goals. The individual will also be responsible for designing and executing different laboratory experiments, making observations, performing data analysis and reporting results.

Qualifications:

0-7 years of work experience in early or late stage formulation development of small molecules.

PhD or Masters degree in Pharmaceutical sciences, chemical engineering or other related scientific disciplines.

Must be well organized, proactive and detail oriented.

Pharmaceutical development experience preferred but not required.

Demonstrated excellence in independently designing and conducting experiments and analyzing data

Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.

Understanding the mechanism of degradation and stabilization of molecules.

Experience in performing early phase formulation/process development of a sterile dosage forms for small molecules.

Strong verbal and written communication skills

Role and Responsibilities:

Exhibit strong scientific acumen, with ability to solve problems of medium/high complexity via independent planning, design, execution and interpretation of experiments

Support the development of robust scalable manufacturing processes and contribute to technology transfers to commercialization partners

Actively participate on development teams and interface with partner functional areas to drive project milestones as required. May represent functional area on project teams

Support the preparation and review of product development reports and related documents

Support regulatory filings for Pre-IND, IND, NDA and ANDAs

Maintain laboratory documentation in accordance to required scientific, regulatory and intellectual property requirements

Support the development and advance of sterile formulation best practices, new technology development and operational excellence

Possess strong organizational, written and verbal communication, and technical writing skills.

Demonstrate good interpersonal skills and the ability to work across multi-disciplinary teams

Equal Opportunity Employer Minorities/Women/Veterans/Disabled