Process Chemist

Job Description

This position will support API manufacturing activities through process improvement, transfer and/or validation in compliance with all applicable guidelines.

What The Job Entails

• Perform all assigned tasks in a timely and organized manner in accordance with relevant cGMP, GLP, and company policies and procedures.
• Ensure high quality in documentation of all necessary and relevant information in a clear concise manner as per cGMPs.
• Develop / improve and/or validate robust API processes, based on quality-by-design and document formal protocols and reports.
• Participate in technical transfer activities, including writing protocols and reports.
• Review experimental data, notebooks, and instrument qualification protocols / reports.
• Actively participate in investigations, problem solving, and troubleshooting. Write investigation reports.
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
• Write, revise, develop, and evaluate SOPs.
• Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
• Provide training and assistance to other group members.
• Support identification and qualification of API related impurities and degradants.
• Maintain good laboratory practices in compliance with safety and environmental requirements.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Performs other related assignments and duties as required and assigned.

Our Ideal Candidate

• Will have a PhD in Chemistry with 5+ years of pharmaceutical analysis. The Principal Scientist will have a PhD with 10+ years of experience. Prior API experience preferred.

• Proven skills in process chemistry of small molecules
• Proven scientific skill and ability to perform complex scientific work independently with no guidance
• Effective in managing multiple competing activities and delivering to timelines
• Ability to work in a cross-function environment
• High level of awareness to innovative technologies and ability to adapt to in-house needs

• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
• Excellent communication skills, both verbal and written