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