Title: Principal Scientist/Associate Director of Analytical Development
Location: Waltham, MA
Entasis is seeking a Principal Scientist or Associate Director in Analytical Development to join their team. In this newly formed role, you will be working with the Associate Director of Analytical Development and you will be responsible for analytical development activities in a virtual CMC environment.
- Manages external analytical vendors
- Reviews and finalizes analytical raw material, in-process, release methods, protocols, reports and stability results
- Maintains high standards of quality and regulatory compliance
- Identifies areas of improvement of analytical methods and trouble-shoots analytical problems
- Provides statistical analysis of analytical results to support stability assessments
- Prepares and reviews analytical chemistry for the CMC section of drug substance and drug product regulatory submission (INDs, IMPD, Briefing Documents)
- Interacts with US and/or EU Regulatory as it relates to questions regarding analytical development
Knowledge and Skill Requirements
- PhD in a science related to Pharmaceutical Analysis with 6+ years working in analytical development in a pharmaceutical or biotechnology environment, experience in a virtual environment a plus
- Excellent technical knowledge of current drug substance and drug product analytical techniques (HPLC, GC, MS, IR, IC, NMR, XRPD)
- Method development and validation expertise
- Ability to perform statistical analysis of analytical results to support stability assessments
- Knowledge of the most current Regulatory/QA/ICH guidance to ensure that all laboratory work and documentation is completed to the highest quality compliance standards
- Experience auditing external analytical suppliers working in GMP/GLP environments
- Familiar with Out of Specification (OOS) investigational procedures and able to conduct them promptly and thoroughly
- Excellent written and oral skills
- Strong organizational skill to manage a large volume of analytical documentation in a controlled manner
- Experienced in representing analytical development on multifunctional teams
- Management experience overseeing analytical group members working in a team-oriented CMC environment.
- Experience with electronic submissions a plus.