Scientist, Chemical Development Engineering

Role Summary

Responsible for independently carrying out research and tasks necessary to develop chemical processes and support scale up and manufacturing of drug substances.

Responsibilities

• May provide engineering support to the chemical development department
• Independently designs, plans and executes activities towards the goals of one or more Chemical Development projects to support preclinical through commercial activities
• Evaluates, develops and implements synthetic changes on Chemical Development projects
• Independently performs process R&D and optimization of synthetic routes, including experimentation for compound preparation, synthetic route scouting, process development and process trouble-shooting
• Supports kilo-lab operations including equipment configuration, maintenance, and operation
• Procures, installs and maintains common-use chemical development instrumentation
• Effectively documents research and development work
• Provides support for off-site synthesis, manufacturing activities and interaction with contractors
• Promotes and ensures a safe environment for operations performed in the laboratory
• Provides training and/or supervision to junior staff, as needed
• Other duties as assigned

Qualifications

• BS/BA degree in chemistry, chemical engineering, or similar scientific discipline AND 2+ years of experience in experience in pharmaceutical/process development field, including API manufacturing experience OR
• MS/MA degree in chemistry, chemical engineering or similar scientific discipline AND some industry experience preferred OR
• PhD in chemistry, chemical engineering or similar scientific discipline AND some relevant experience preferred
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• A thorough understanding of organic and process chemistry, as well as familiarity with current literature and the ability to search the literature
• Understanding manufacturing and cGMP requirements in Chemical Development is a plus
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Ensures laboratory work is done productively and practices safe laboratory skills
• Performs process R&D and optimizes synthetic routes
• May provide input for portion(s) of CMC regulatory documentation and supporting work
• Drug substance process development, scale up, and manufacturing experience is a plus
• Mechanical inclination is a plus
• Good knowledge of scientific principles, methods and techniques
• Strong computer skills
• Good communications, problem-solving, analytical thinking skills
• Detail oriented
• Ability to meet deadlines
• Good project management and interpersonal skills
• Ability to creatively solve complex problems in a team environment
• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
• Effective report writing, and oral presentations skills

Education

• Not specified beyond degree requirements listed in Qualifications