The Scientist/Senior Scientist, Process Chemistry will be part of a dynamic team that supports the process development activities pertaining to the research, development, and scaleup of Active Pharmaceutical Ingredients (APIs). This individual will be responsible for the experiments leading up to the IND and NDA filing of new chemical entities, as well as designing and conducting experiments for the development of new synthetic routes and optimization of existing synthetic routes for APIs leading to scalable processes. Additional responsibilities include planning, execution, and documentation of all project related experimentation and the evaluation of the corresponding results, as well as collaborating with project leaders in other departments to ensure adherence to project timelines. As a member of the Chemistry and CMC teams, this person will provide support for development of the GMP process at the Contract Manufacturing Organizations and will have visibility into the Chemical Development and Regulatory strategy.

Responsibilities:

• Identify, prioritize, and evaluate potential routes of synthesis of target molecules
• Identify, prepare, and characterize impurities and degradation products
• Conduct spiking experiments in support of pre-validation studies
• Perform crystallization studies on intermediates or final APIs
• Provide guidance and support to analytical and drug product departments
• Manage all support tasks required to maintain a functioning chemical laboratory, for example ordering chemicals, supplies, organizing waste disposal
• Prepare and follow standard operating procedures
• Be a leader in the establishment of safe and efficient work practices
• Write experimental protocols and technical reports capturing details of the experiments conducted and conclusions drawn
• Write progress reports and give presentations at weekly project meetings
• Maintain laboratory notebooks for all experimental work performed

Qualifications:

• PhD, Organic Chemistry is required
• A minimum of two years post-graduate experience as a synthetic chemist is required
• Experience in the pharmaceutical industry is strongly preferred
• Possess a proven track record in conducting scientific research, with highly developed problem solving and decision-making skills
• An established publication record is required. Authorship of patents is a plus.
• Excellent verbal and written communication skills
• Proficiency in computer applications, including MS Office and SciFinder is highly desirable